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- 2026-04-04 11:56:48
- Policy
- Celltrion has added 'Omlyclo' Pen Inj…rival Xolair
- by Lee, Tak-Sun Dec 23, 2025 07:59am
- Celltrion's 'Omlyclo'Celltrion has started chasing the original product in the Korean market through the expanded formulation of 'Omlyclo (omalizumab)', used to treat allergic asthma and chronic spontaneous urticaria.The original drug is Novartis' Xolair, an injectable generating KRW 20 billion in the domestic market (KRW 21.1 billion according to the 2023 IQVIA). Omlyclo is a biosimilar to Xolair, and it was added to the reimbursement list in September of last year.The Ministry of Food and Drug Safety (MFDS) approved Omlyclo Pen Inj in September. This product is a pen formulation, a different formulation from Omlyclo PFS Inj approved in June of last year.The difference between a pre-filled pen and a pre-filled syringe is whether the needle tip is exposed. A pre-filled syringe is injected with a needle exposed, while a pre-filled pen may reduce fear due to its hidden needle tip. Both formulations can be self-injected.The original drug Xolair has no pen formulation approved in South Korea. Only the conventional injectable and pre-filled syringe formulations are available.Considering these factors, Celltrion may be one step ahead in the future competition against Xolair.When it comes to prices, Celltrion has a competitive edge. Xolair is priced at KRW 216,755 per 150mg. In contrast, Omlyclo costs KRW 173,404, approximately KRW 40,000 less.However, Omlyclo 300mg of higher strength has not yet been added to the reimbursement list, thereby constituting the current weakness.Product sales overseas are also at full scale. In September, it was launched in Europe. In Europe, Omlyclo is reportedly the sole biosimilar to omalizumab.Omlyclo obtained U.S. FDA approval in March, thereby beginning to target the North American market on a full-scale basis.However, due to the patent expiration of Xolair in November, other biosimilars, such as one from Teva Pharmaceutical, are about to enter the market. Celltrion taking the market lead in the early race is expected to drive sustained sales.Xolair's global sales amounted to approximately KRW 5 trillion as of 2023.
- InterView
- [Desk View] Thoughts on 18-year economic evaluation system
- by Eo, Yun-Ho Dec 22, 2025 08:54am
- Anticipation and concerns are remaining as the reform of the drug pricing system in 2026 is approaching.Amid the anticipated introduction of various regulatory frameworks and drug price-reduction measures, as a journalist covering multinational pharmaceutical companies, I am closely monitoring potential shifts in South Korea's economic evaluation system.It has been approximately 18 years since the economic evaluation system was first introduced as part of the 2007 Drug Expenditure Rationalization Plan. It has been more than enough time to identify systemic flaws and determine necessary improvements.Economic evaluation is a tool for assessing the cost-effectiveness of a drug. The majority of new medicines must undergo this process for insurance reimbursement listing.In principle, economic evaluation is straightforward. It measures clinical benefit against cost to determine how much more the payer is willing to spend. However, because these are new drugs, economic evaluations involve numerous assumptions, ranging from treatment duration and the extent of clinical efficacy recognized to endpoint selection, extrapolation, and weighting. Consequently, the structure is such that reimbursement is based entirely on which assumptions are accepted.The pace of new drug listing in South Korea is reportedly slower than in other major economies. Economic evaluation is cited as the primary cause. If it is such a simple tool, why does it take so long? It is because a consensus must be reached on those aforementioned assumptions. Every single underlying assumption requires total agreement.Because acceptance of these assumptions determines the Incremental Cost-Effectiveness Ratio (ICER) and, subsequently, the price, this process becomes a battle in which neither side can easily concede. We must reconsider whether spending this much time at this stage is truly the right direction.Depending on the assumptions made, a drug can be considered a cost-effective treatment or dismissed as unacceptably expensive. Currently, drug characteristics vary significantly not only across different therapeutic areas but even within the same disease category. However, the government’s actual evaluative criteria remain extremely limited. In contrast, looking at evaluation results from agencies such as the UK’s NICE, one can see instances in which manufacturer-proposed assumptions are accepted even when they deviate from traditional methods.Experts argue that, since assumptions in economic evaluations involve uncertainty, efforts must be made to minimize it. However, this is directly linked to the speed of new drug adoption. Minimizing uncertainty inevitably requires a significant amount of time. The real question is whether such a process actually reduces that uncertainty.For drugs with high clinical need, cost-effectiveness can be sufficiently demonstrated if different assumptions are applied. In other words, flexibility in evaluation can accelerate market entry. For more radical reform, we could consider a system that categorizes ICER ranges and determines drug prices accordingly.Similar to France's ASMR, South Korea could establish pricing criteria based on value, using scores for different ICER ranges as one component of the value judgment. It is finally time for a serious re-evaluation of the current system, where economic evaluation serves as the final stage of drug pricing.
- Company
- Reimb remains urgent for severe alopecia areata treatment
- by Eo, Yun-Ho Dec 22, 2025 08:54am
- The South Korean government shows intent to expand hair-loss reimbursement, drawing industry attention to the related measures to follow.Recently, during a policy briefing for the Ministry of Health and Welfare (MOHW), President Lee Jae Myung stated that hair loss is not merely a cosmetic issue but a disease that can affect an individual's quality of life, dignity, and even their survival. The awareness of a problem has been proposed that hair loss, long dismissed as an issue of aesthetics and grooming, must be re-evaluated from a public health perspective.Notably, the daily lives of patients with severe alopecia areata are severely affected compared to those with hormonal or age-related hair loss.Severe alopecia areata is an autoimmune disorder characterized by the loss of scalp hair, as well as eyebrows, eyelashes, and body hair. Patients experience extreme social stigma and psychological distress due to these physical changes, which often lead to professional disadvantages, social isolation, and mental health issues such as depression and anxiety.While the Janus kinase (JAK) inhibitor 'Olumiant (baricitinib)' is approved in Korea for severe alopecia areata, the process for expanding its reimbursement has faced prolonged delays.Olumiant is an oral, reversible, selective JAK inhibitor already covered by national health insurance for atopic dermatitis and rheumatoid arthritis. In September 2024, the developer, Eli Lilly, applied for reimbursement expansion for three indications: pediatric atopic dermatitis, severe alopecia areata, and pediatric idiopathic arthritis.The issue lies in the different speed of progression of the reimbursement reviews for these indications. In the case of pediatric atopic dermatitis, reimbursement was finalized just two months after it was reported to the MOHW, following discussions by the Drug Reimbursement Criteria Subcommittee.In contrast, despite completing subcommittee discussions and the ministry report, the review of severe alopecia areata has remained stalled for approximately 5 months, with no procedural progress. Given that a financial impact review order is typically issued within one month of a report to the ministry, this delay is considered highly unusual.The severe alopecia areata indication has faced the longest delay among the three simultaneous applications. While the pediatric idiopathic arthritis application concluded with a non-reimbursement decision at the criteria-setting stage, severe alopecia areata remains in a prolonged 'under review' status. Despite identical product and application dates, a significant disparity in reimbursement access has emerged by specific indication.Under the current system, different officials are assigned to review each indication. Consequently, the actual processing speed varies significantly based on individual workloads, review sequences, and policy priorities. This structure means that, even for the same drug, a patient's access to reimbursement can change simply based on 'which reviewer is assigned to a specific indication'.For patients, it is difficult to understand why access to treatment for a drug with the same mechanism and active ingredient differs solely based on the government's internal review order across various indications. For those with severe alopecia areata, where social isolation and mental burden are high due to the nature of the disease, reimbursement delays are not merely administrative issues but matters that affect their entire lives.Professor Yong Hyun Jang, a professor of dermatology at Kyungpook National University Hospital (Insurance Director of the Korean Dermatological Association), stated, "Alopecia areata is not a cosmetic issue but an autoimmune disease caused by immune abnormalities. In severe stages, if the treatment window is missed, recovery becomes difficult. Despite the existence of clinically proven treatments, many patients cannot start therapy due to cost or are forced to stop mid-treatment for financial reasons."Professor Jang emphasized, "Treatments for severe alopecia areata must be viewed as essential medical care to protect a patient's daily life and mental health, not as cosmetic improvement. Discussions on poclies are necessary to improve access to treatments that have sufficient clinical evidence."
- InterView
- ‘Adempas, effective alternative for patients with inadequate response to PDE5i’
- by Son, Hyung Min Dec 22, 2025 08:53am
- ‘The ultimate goal for PAH is to reach and maintain a low-risk status. If this goal is not achieved or the risk level is not sufficiently lowered, an early change in treatment strategy is essential.”Switching to Bayer’s sGC stimulator ‘Adempas (riociguat)’ is emerging as a practical treatment strategy for patients with PAH who do not show sufficient response to PDE5 inhibitors. With the recent establishment of reimbursement criteria in Korea, experts note that a turning point has been created in a treatment landscape that has long relied on sequential monotherapy.Vallerie McLaughlin, Professor of Cardiovascular Medicine at the University of Michigan Medical Center, and Wook-Jin Chung, Professor of Cardiology at Gachon University Gil Medical Center, recently emphasized the clinical potential of Adempas in PAH treatment during a recent interview with Daily Pharm.Vallerie McLaughlin, Professor of Cardiovascular Medicine at the University of Michigan Medical Center, Wookjin Jeong, Professor of Cardiology at Gachon University Gil Medical CenterPulmonary hypertension, characterized by abnormally elevated pulmonary arterial pressure, is classified into five groups based on etiology. Among these, Group 1 PAH and Group 4 chronic thromboembolic pulmonary hypertension (CTEPH) are considered rare diseases, accounting for only about 3% of all pulmonary hypertension patients each. Often beginning with nonspecific symptoms like shortness of breath, fatigue, and dizziness, patients frequently attribute these to aging or are misdiagnosed with other conditions at primary care facilities, leading to significant diagnostic delays.PAH is known to be a severe, life-threatening condition, with a mortality risk within 2-3 years if left untreated. In Korea, the number of diagnosed patients has increased due to greater physician awareness, efforts toward early detection, and wider use of right heart catheterization. However, concerns remain that the domestic treatment environment still diverges in part from global clinical guidelines.Unlike international guidelines that recommend initial combination therapy with endothelin receptor antagonists (ERA) and phosphodiesterase type 5 inhibitors (PDE5i) from the outset, sequential monotherapy-based treatment strategies remain commonly applied in Korea.PAH treatments are categorized by mechanism of action into: ▲ Endothelin receptor antagonists (ERAs) ▲ Nitric oxide pathway targeted therapies (PDE5 inhibitors, sGC stimulators) ▲ Prostacyclin analogues (PCAs) ▲ Prostaglandin receptor agonists (PRAs). Global guidelines recommend initiating treatment with a combination of ERA and PDE5 inhibitors from the outset, escalating treatment by adding agents with different mechanisms, such as PCA or PRA, when treatment response is inadequate. This strategy aims to maximize therapeutic efficacy by simultaneously targeting multiple pathophysiological pathways.In contrast, the domestic approach has primarily involved initiating treatment with ERA monotherapy, adding a PDE5 inhibitor if response is inadequate, and subsequently combining PCA or PRA if improvement is still lacking. However, studies report that despite the use of a combination of ERA and PDE5 inhibitors, some patients experience clinical deterioration due to inadequate response to PDE5 inhibitors or issues related to tolerability.In this context, Adempas (riociguat), an sGC stimulator, is gaining attention as a potential treatment option to replace PDE5 inhibitors.In the REPLACE study, which enrolled adult patients with symptomatic pulmonary arterial hypertension (PAH) who showed an inadequate clinical response to PDE5 inhibitor therapy, patients who switched from a PDE5 inhibitor to Adempas achieved a 2.78-fold higher rate of clinical improvement at 24 weeks compared with those who continued PDE5 inhibitor treatment. and a 90% reduction in the risk of clinical worsening.Based on this evidence, the 2022 ESC/ERS (European Society of Cardiology/European Respiratory Society) pulmonary hypertension treatment guidelines also recommend switching from PDE5 inhibitors to sGC stimulators in patients who fail to reach treatment goals despite ERA and PDE5 inhibitor combination therapy.Accordingly, reimbursement criteria for Adempas were newly established in Korea starting this June. Reimbursement is now granted for patients with PAH (WHO Group 1) in WHO functional class II-III who either ▲show insufficient response to ERA and/or PDE5 inhibitor therapy or ▲have contraindications to both ERA and PDE5 inhibitors. This is expected to serve as a new treatment strategy that can improve patient status before escalating to triple combination therapy.Amid these changes, the two professors emphasized, “Suspicion is the starting point in pulmonary hypertension. Alongside the importance of early diagnosis, treatment goals should be set to reach and maintain the low-risk status, with treatment strategies flexibly adjusted based on patient response.”Q. Please explain the main symptoms and causes of pulmonary arterial hypertension, along with its severity.Professor Vallerie McLaughlin: PAH is characterized by prominent shortness of breath during exercise or activity. While the timing varies among patients, they commonly experience dyspnea. In fact, many patients seek medical care primarily due to this shortness of breath. Other symptoms include fatigue, dizziness, chest pain, and leg swelling. These symptoms are non-specific and can commonly occur in other diseases, often leading to delayed diagnosis.PAH is a rare disease. While some cases are idiopathic with no identifiable cause, they can also result from genetic factors, specific medications, dietary habits, or conditions like connective tissue disorders, liver disease, or heart failure.Professor Wook-Jin Chung: The hallmark symptom of PAH is shortness of breath when climbing stairs or hills. Patients may not feel breathless on flat ground, but even mild exertion, such as ascending stairs, can provoke significant dyspnea. Diagnosis is often delayed because symptoms such as fatigue, dizziness, and chest pain are nonspecific.Although advances in drug development have made PAH a more manageable condition, prognosis remains poor. Therefore, prompt evaluation by specialized clinicians, accurate diagnosis, and appropriate treatment are critically important.Q. How do the treatment environments for pulmonary arterial hypertension differ between the United States and Korea?Vallerie McLaughlin, Professor of Cardiovascular Medicine at the University of Michigan Medical CenterProfessor Vallerie McLaughlin: In the United States, 13 PAH drugs have already received FDA approval and are available for use. In practice, many patients are using a diverse class of medications, including endothelin pathway–targeting agents (ERA), prostacyclin pathway–targeting agents (PCA, PRA), and nitric oxide pathway–targeting agents (PDE5 inhibitors and sGC stimulators).Patients classified as high risk require more intensive treatment. For these patients, triple combination therapy may be considered, including intravenous prostacyclin pathway agents in combination with endothelin or nitric oxide pathway therapies.Patients in the intermediate-risk or low-risk groups receive dual therapy based on oral medications, using agents such as ERAs or nitric oxide pathway therapies, including PDE5 inhibitors or sGC stimulators.Initial treatment, however, is only the first step. After 3-4 months of treatment initiation, the patient's risk level must be periodically reassessed using objective evaluation tools. If treatment goals have been achieved, the current regimen can be maintained. However, if the risk level remains insufficiently reduced, treatment intensity must be escalated. Strategies such as triple combination therapy or switching from the previously used PDE-5 inhibitor to an sGC stimulator can be considered. This re-evaluation process is repeated thereafter, with the ultimate treatment goal of achieving and sustaining a low-risk status for the patient.Professor Wook-Jin Chung: Globally, the development of PAH therapies gained momentum with the launch of epoprostenol in 1995. In Korea, effective treatment became possible in 2005, when Bayer’s Ventavis (iloprost) was approved for reimbursement.In the past, treatment escalation was typically initiated only after clinical deterioration. However, because PAH is difficult to cure, waiting for disease progression before intensifying treatment is highly risky and insufficient to reduce mortality. Consequently, recent treatment strategies follow the principle of guideline-directed medical therapy (GDMT), which emphasizes a goal-oriented approach—lowering risk early, achieving a low-risk state, and maintaining it over time.In addition to guiding patients toward a low-risk status, another important treatment goal is to normalize hemodynamic parameters as much as possible.The minimum goal is to sustain a low-risk state by maintaining a mean pulmonary artery pressure (mPAP) ≤40 mmHg and pulmonary vascular resistance (PVR) ≤4 Wood units. Some patients achieve near-normal levels, such as a mPAP ≤20 mmHg and PVR ≤2 Wood units.Injection therapy is required in only about 10% of all patients, and the majority of patients can achieve hemodynamic goals with oral therapies alone.Q. Please share any treatment challenges you have encountered in clinical practice.Wook-Jin Chung, Professor of Cardiology at Gachon University Gil Medical CenterProfessor Wook-Jin Chung: One of the main challenges in treatment is that several therapies used globally have not yet been introduced in Korea. While 13 types of medications are used globally, 4 of them have not been introduced in Korea. Even among the approved drugs, some are not covered by reimbursement, limiting patient access.According to the National Cancer Information Center, Korea's overall five-year cancer survival rate (2018-2022) is approximately 72.9%, whereas the five-year survival rate for PAH is 71.9%. Given that PAH has a poorer prognosis than cancer, government support is essential.Only a portion of PAH patients qualify for a special calculation exception, and even then, this is limited to idiopathic pulmonary arterial hypertension (IPAH). PAH is a high-cost disease where treatment is virtually impossible without insurance support. Therefore, beyond IPAH, it is necessary to expand special reimbursement programs to include PAH caused by other etiologies, based on accurate disease classification.In Korea, PAH treatment typically begins with ERA, with PDE-5 inhibitors added if the response is insufficient. However, there was no subsequent alternative for patients who did not respond adequately to PDE-5 inhibitors. Since intravenous formulations were not introduced domestically, subcutaneous injection and inhalation formulations of prostacyclin pathway-targeted therapies were used.With the recent inclusion of Adempas under reimbursement, a new option has emerged. As an sGC stimulator, Adempas produces a strong vasodilatory effect even at low doses, making it a powerful option for patients who do not respond adequately to PDE-5 inhibitors. It can be used immediately as a switch option in patients with poor PDE-5 inhibitor response and is also available in cases where PDE-5 inhibitors are contraindicated. Clinically, this represents a highly meaningful and practical addition to the treatment landscape.Q. Adempas has been used clinically in the US for a long time. How would you assess its clinical value?Professor Vallerie McLaughlin: Adempas has been used as a treatment for PAH in the US for over a decade, accumulating substantial clinical data over this extended period.Adempas is a drug that directly promotes cGMP production, independent of nitric oxide (NO) levels in the body. Unlike PDE-5 inhibitors, it induces vasodilation and achieves therapeutic effects for PAH in an NO-independent manner, even without the precursor substance NO.In the PATENT clinical trial, which confirmed the therapeutic efficacy and safety of Adempas compared to placebo, significant improvements were observed in exercise capacity (including the 6-minute walk test), pulmonary vascular resistance, and cardiovascular markers, including NT-proBNP, compared to placebo.In addition, the REPLACE study compared treatment outcomes by dividing patients previously receiving combined ERA and PDE-5 inhibitor therapy into two groups: one maintaining existing therapy and the other switching the PDE-5 inhibitor to Adempas. Results showed the clinical improvement rate upon switching to Adempas was 2.78 times significantly higher than in the group that continued PDE-5 inhibitor therapy.Given Korea’s limited access to PAH therapies, switching to Adempas represents an effective alternative for patients who show an inadequate response to PDE-5 inhibitors.Q. What is the value of using Adempas for the treatment of CTEPH?Professor Wook-Jin Chung: Adempas is the only medication available for patients with chronic thromboembolic pulmonary hypertension (CTEPH) and has been used worldwide for over a decade. However, in Korea, it is not covered by insurance, resulting in low patient access.The estimated number of CTEPH patients is nearly comparable to that of pulmonary arterial hypertension patients, but only about 300 to 400 patients actually receive treatment, such as surgery or interventions. Adempas is beneficial for CTEPH patients who still have residual pulmonary artery pressure after intervention or for those who are ineligible for surgery or procedures.Given its strong clinical evidence, it is essential to establish a KCD code for CTEPH and ensure access to the drug through reimbursement coverage. Academic societies plan to continue discussions with the National Assembly and HIRA on this issue.Professor Vallerie McLaughlin: Adempas is the only FDA-approved treatment for CTEPH and has been used in real-world clinical practice in the United States for over a decade.It is indicated for patients with CTEPH whose occluded vessels are too small for surgical or interventional procedures like pulmonary endarterectomy or balloon angioplasty, or for whom pulmonary artery pressure remains elevated after such procedures.Even among patients who undergo pulmonary endarterectomy, pulmonary artery pressure sometimes remains persistently high after surgery. Because persistently high pressure negatively impacts prognosis, pulmonary artery pressure is reassessed at 6 months post-surgery via right heart catheterization. According to UK research, patients whose mean pulmonary artery pressure does not decrease below 35 mmHg post-surgery are known to have a very poor prognosis. For these patients, measures to lower pulmonary artery pressure using Adempas are implemented.There is also evidence that pre-treatment with Adempas before balloon pulmonary angioplasty can reduce surgical risk. Based on these data, Adempas is actively used across various CTEPH patient populations, with successful clinical outcomes.Q. What treatment options are used for CTEPH patients who are not eligible for surgery or intervention?Professor Wook-Jin Chung: Some patients are currently using PDE-5 inhibitors without reimbursement, which reflects the treatment gap caused by the unavailability of Adempas. This highlights the urgent need to establish a KCD code and reimbursement coverage for CTEPH.Professor Vallerie McLaughlin: ERA-class drugs were studied in CTEPH patients in the past, but the results were not successful. Adempas is the only therapy that has demonstrated significant efficacy in CTEPH, and because there are no viable alternatives, the need for its access is even more pressing.Q. What recommendations would you make to improve the pulmonary hypertension treatment environment?Professor Vallerie McLaughlin: Raising awareness of the disease is paramount. Because pulmonary hypertension presents with highly nonspecific symptoms, diagnosis is often delayed. The media also plays a crucial role in this process. Providing the public with clear information about symptoms that should raise suspicion of pulmonary hypertension can greatly facilitate early diagnosis and treatment.Given that experts have already established a robust clinical network, specialized institutions should take on a central role as pulmonary hypertension referral centers. This would enable efficient referral systems, allowing suspected cases identified in primary care settings to be promptly transferred to specialized centers. Clinicians should perform appropriate risk assessments each time a patient visits the hospital and, when necessary, stepwise intensify treatment to reduce risk and lower long-term mortality.Professor Wook-Jin Chung: In Korea, expanding access to medications is the first priority. Introducing new drugs and using them appropriately according to guidelines is crucial for improving treatment outcomes.Furthermore, designating and operating specialized pulmonary hypertension centers is essential. The designation of these so-called ‘Centers of Excellence’ significantly impacts treatment outcomes. Therefore, government-level support is absolutely necessary. I would like to emphasize that a specialized pulmonary hypertension center covering all five types of pulmonary hypertension, not just PAH, needs to be established.We plan to continue the “Lung, Early” awareness campaign to improve understanding of pulmonary hypertension among the public, healthcare professionals, and policymakers, and to maintain discussions with pharmaceutical companies and the government to facilitate access to new therapies. We are also collecting data and conducting research to build a patient-centered treatment environment in Korea, with ongoing efforts to improve care across the entire spectrum of pulmonary hypertension, including PAH.Some patients use PDE-5 inhibitors without reimbursement, but this represents the treatment gap arising from the inability to use Adempas. This underscores the urgency of establishing a new KCD code for CTEPH and securing insurance coverage.
- Company
- Will silymarin reimb reversal be overturned?
- by Kim, Jin-Gu Dec 22, 2025 08:53am
- In a lawsuit challenging the Ministry of Health and Welfare's decision to remove ‘silymarin (milk thistle extract)’ products from the reimbursement list following a reimbursement adequacy reassessment, Bukwang Pharmaceutical secured a reversal victory on appeal.The case has drawn significant attention from the pharmaceutical and biotech industry as it marks the first instance where the Seoul High Court overturned a lower court ruling and recognized the clinical utility of an active ingredient that had failed a reimbursement adequacy reassessment.Bukwang Pharmaceutical overturns first instance loss, successfully demonstrates ‘clinical utilityAccording to industry sources on the 19th, the 9-1 Administrative Division of the Seoul High Court ruled in favor of the plaintiff in the lawsuit filed by Bukwang Pharmaceutical against the Minister of Health and Welfare seeking the ‘revocation of the partial amendment notice of the drug reimbursement list and reimbursement ceiling price table’. This overturns the Seoul Administrative Court's first-instance ruling in favor of the Ministry of Health and Welfare, accepting Bukwang Pharmaceutical's arguments.The key issue in this lawsuit was whether the ‘clinical utility’ of the silymarin component would be recognized. Silymarin was subject to a reimbursement adequacy reassessment in 2021 alongside ▲bilberry dry extract ▲avocado-soybean unsaponifiables ▲Vitis vinifera (grape seed extract) ▲Ginkgo biloba dry extract.Following the reassessment, the government concluded that silymarin lacked reimbursement adequacy, citing insufficient academic evidence to support its clinical utility. In November of that year, the Ministry formally announced the removal of reimbursement coverage for silymarin products.In response, pharmaceutical companies filed administrative lawsuits and sought injunctions to suspend enforcement. Bukwang Pharmaceutical, which markets the silymarin product Legalon, filed a separate lawsuit, while six other companies—including Samil Pharm, Suheung, Young Il Pharm, Korea Pharma, Hutecs Korea Pharmaceutical, and HanAll Biopharma—jointly filed a related suit.After more than two years of litigation, the Seoul Administrative Court issued its first ruling in November 2023, finding the reimbursement removal lawful and ruling in favor of the government.The pharmaceutical companies appealed, and the appellate court took a markedly different view. During appellate proceedings, Bukwang submitted additional evidence, including SCIE-indexed academic papers, to substantiate the clinical utility of silymarin. The court determined that this body of literature was sufficient to support the ingredient’s clinical utility.First case where the court recognized clinical utility. … Industry interest risesWhile multiple administrative lawsuits have challenged reimbursement adequacy reassessment outcomes in the past, no court had previously accepted a pharmaceutical company’s claim regarding clinical utility.In a 2023 case involving bilberry dry extract, a pharmaceutical company prevailed at first instance; however, the court at that time cited procedural flaws in the reassessment process rather than recognizing clinical utility. Ultimately, bilberry dry extract failed to secure final recognition of clinical utility on appeal and was removed from the reimbursement list.By contrast, the silymarin ruling directly addresses the substantive issue of clinical utility, rather than administrative procedure. It represents the first case in which a court explicitly acknowledged the effectiveness of a drug ingredient based on academic evidence submitted by a pharmaceutical company, overturning the government’s determination that the drug lacked sufficient efficacy.Reimbursement for Legalon maintained… potential ripple effects on ongoing lawsuitsAs a result of the appellate victory, Bukwang Pharmaceutical will be able to maintain reimbursement coverage for Legalon. While Legaron's reimbursement was preserved during the lawsuit due to the court's injunction, this ruling is seen as further solidifying its legal standing for reimbursement.Industry observers expect the government to appeal to the Supreme Court to seek a final judgment. However, given that the appellate court explicitly acknowledged the value of the clinical evidence, analysts suggest that pharmaceutical companies may hold a stronger position in any further proceedings.The ruling is also expected to influence other ongoing lawsuits involving silymarin products filed by companies such as Samil Pharmaceutical, as the legal issues at stake are essentially identical.According to pharmaceutical market research institute UBIST, outpatient prescription sales of silymarin products increased by 45% over three years, from KRW 23.6 billion in 2019 to KRW 34.1 billion in 2022. However, following the failure of the reimbursement reassessment, many products were removed from the reimbursement list, leading to a contraction of the market. Currently, only products from seven companies involved in litigation with the government continue to receive reimbursement coverage. Cumulative prescription sales for these products reached KRW 17.5 billion in the third quarter of this year, representing a 5% year-on-year decline. For Legalon, cumulative third-quarter prescription sales fell 11%, from KRW 12.1 billion to KRW 10.8 billion.
- Company
- 'Elahere' launches in KOR…AbbVie's ADC success
- by Son, Hyung Min Dec 22, 2025 08:53am
- New ADC drug 'Elahere'AbbVie is rapidly expanding its oncology portfolio with a series of successful new Antibody-Drug Conjugate (ADC) commercializations.AbbVie secured the first ADC approval for ovarian cancer and is now addressing unmet needs in non-small cell lung cancer (NSCLC) with the approval of a c-Met-targeting ADC.According to industry sources on December 20, AbbVie obtained domestic approval for its new platinum-resistant ovarian cancer (PROC) ADC, 'Elahere (mirvetuximab soravtansine)', in South Korea on December 19.The specific indication is for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.Elahere is an ADC targeting FRα-expressing ovarian cancer, utilizing a mechanism that delivers the potent cytotoxic payload DM4 directly into cancer cells to induce tumor cell death. It is garnering significant attention as a new option for ovarian cancer patients who have developed resistance to platinum-based chemotherapy. As the first new mechanism-of-action drug for platinum-resistant ovarian cancer in approximately 10 years, it was designated as an orphan drug in South Korea this past January.Elahere is a first-in-class ADC that includes an FRα-binding antibody, a cleavable linker, and maytansinoid payload DM4, a potent microtubule inhibitor, designed to kill targeted cancer cells.In epithelial ovarian cancer, which accounts for 90% of all ovarian cancer cases, taxanes like paclitaxel and platinum-based agents like carboplatin and cisplatin are primarily used. However, in cases of recurrent ovarian cancer resistant to platinum agents, response rates to the current standard-of-care chemotherapy have been generally low, significantly limiting improvements in survival rates. Elahere proved to be a viable alternative through the Phase 3 MIRASOL study conducted on PROC patients.In the MIRASOL study, Elahere demonstrated a 35% reduction in the risk of disease progression or death compared to existing non-platinum-based chemotherapy.The median progression-free survival (PFS) was 5.62 months, an improvement over the 3.98 months in the control group. The objective response rate (ORR) was 42.3%, significantly higher than the 15.9% observed in the standard chemotherapy group.Median overall survival (OS) was 16.85 months, reducing the risk of death by 32% compared to the 13.34 months in the control group.Regarding safety, adverse events such as ocular reactions, fatigue, and abdominal pain were reported and generally considered manageable.Based on these clinical achievements, Elahere received approval in the U.S. in March of last year and in Europe in November of the same year.The U.S. NCCN guidelines recommend Elahere as a "preferred regimen" (Category 1) for the treatment of FRα-positive PROC patients, and the Korean Society of Gynecologic Oncology also recommends Elahere with the highest level of evidence (Level I, Grade A).Commercialization of c-Met-targeting 'Emrelis' in NSCLCNew ADC drug 'Emrelis'AbbVie also succeeded in ovarian cancer by commercializing an ADC for non-small cell lung cancer, following its success in ovarian cancer.In May, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the c-Met-targeting ADC 'Emrelis (telisotuzumab vedotin)' for adult patients with previously treated locally advanced or metastatic non-squamous NSCLC with c-Met protein overexpression.c-Met is a protein expressed by the mesenchymal-epithelial transition (MET) gene. As a protein that transmits signals to cells, c-Met is considered a major oncogenic driver and is associated with the development of various solid tumors, including colorectal, gastric, and liver cancers, as well as NSCLC. It is known that c-Met alterations occur in approximately 6% of patients with NSCLC.Currently, AbbVie’s Emrelis is the only commercialized ADC targeting c-Met alterations.Emrelis's approval was based on improvements in key endpoints, such as ORR and duration of response (DOR). It is expected to transition to full approval if clinical benefit is confirmed in a confirmatory trial.Analysis of 84 patients with c-Met overexpression in the Phase 2 LUMINOSITY study showed an ORR of 35% and a median DOR of 7.2 months in the Emrelis arm.Major adverse events included peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. Grade 3–4 adverse events reported included lymphopenia, increased liver enzymes, and electrolyte imbalances.Based on this clinical data, Emrelis was also designated as a Breakthrough Therapy by the FDA in 2021.Currently, Emrelis is under another evaluation as a monotherapy in the Phase 3 confirmatory TeliMET NSCLC-01 study.
- InterView
- Korea Is a key market… will turn neuroscience innovation into reality”
- by Son, Hyung Min Dec 19, 2025 09:09am
- Brad Edwards, Managing Director of Lundbeck KoreaLundbeck, a global pharmaceutical company specializing in central nervous system (CNS) drug development, has established a solid foothold in Korea's mental health treatment sector through antidepressants like ‘Brintellix (vortioxetine bromide)’ and ‘Lexapro (escitalopram oxalate)’.Recently, it has expanded its portfolio beyond mental illness to include rare neurological disorders, further clarifying its identity as a neuroscience-focused company.Amidst this transformation, Lundbeck Korea appointed its first foreign Managing Director in April, 23 years after the company's establishment in Korea. The new leader is Brad Edwards. He is an expert with nearly 30 years of experience at global pharmaceutical companies, including Pfizer, Shire, and Takeda, having led operations across Australia, New Zealand, and other emerging markets. Most recently, he was based in Singapore as Takeda's Head of Plasma-Derived Therapies, Growth and Emerging Markets.Edwards stated, “While working in Singapore, I never anticipated I would be working in Korea, but Korea is an attractive market with scientific prestige and clinical capabilities. I am greatly inspired by the Korean Lundbeck team's efforts to make a tangible difference in patients' lives through brain health.”“Introducing innovative products... strengthens patient-centric approach strategy”Edwards assessed Korea as a key hub for realizing neuroscience innovation within Lundbeck's global strategy. He noted that Korea is one of Lundbeck's 12 designated core markets, possessing clinical trial capabilities, scientific infrastructure, a digital health environment, and progressively improving regulatory and reimbursement policies.Edwards explained, “The Korean government has recently introduced various forms of regulatory flexibility to improve access to innovative medicines, including faster approval pathways, conditional approvals, and risk-sharing schemes. Policies aimed at reducing out-of-pocket costs for patients with rare and severe diseases, as well as improving diagnosis rates, are also positive developments.”He noted that these environmental changes are laying the groundwork for Korean patients’ faster access to new innovative therapies.Lundbeck Korea’s strategy goes beyond simply launching new drugs. The company envisions redesigning the entire patient access pathway, strengthening collaboration with patient advocacy groups and medical communities while addressing institutional factors such as regulatory approval, reimbursement, and pricing. Preparations for new product launches, pending domestic approval, are already underway.Edwards stated, “Our top priority is introducing innovative new products to the Korean market and improving the lives of Korean patients with brain disorders. To achieve this, we plan to continuously strive to make not only the products themselves but also our approach to patients more efficient and truly patient-centric.”From an organizational perspective, Lundbeck Korea is also built on a stable foundation. Within a culture that emphasizes employee engagement and diversity, the company has earned Great Place to Work certification for two consecutive years, while maintaining a balanced organizational structure across gender and generations.Edwards stated, “This kind of organizational culture is a critical foundation for delivering sustainable, long-term performance. I hope to continue the successful operating practices that Lundbeck Korea has built over the years.”Focus on Neuroscience and Rare Diseases… Accelerates Portfolio TransformationNeuroscience and rare diseases are the most critical pillars of Lundbeck’s mid- to long-term strategy. Globally, the company is reshaping its portfolio around rare neurological diseases, with Korea positioned as a key part of this effort.Edwards said, “Many patients with rare neurological diseases remain undiagnosed, resulting in significant unmet medical needs. By pursuing new scientific approaches and driving neuroscience innovation, we aim to improve patients’ quality of life. This aligns directly with Lundbeck’s goal of expanding an innovative and specialized portfolio in rare neurological diseases.”He added, “Lundbeck is shifting its focus within neuroscience toward rare neurological disorders. Based on our extensive experience working in the rare disease field across multiple countries, we expect Lundbeck Korea to contribute to this transformation process.”The antidepressant business continues to be an important pillar for Lundbeck Korea. Brintellix and Lexapro remain flagship products and have been widely used in Korea’s mental health treatment landscape for many years.Edwards said, “Mental health is both a core business area and a long-term responsibility. We will continue to ensure stable supply, education, and digital support for antidepressant therapies through close collaboration with healthcare professionals and partners.”From a global strategy perspective, Edwards emphasized that Korea plays a crucial role in connecting global R&D capabilities with local innovation.He stated, “Korea has excellent clinical execution capabilities and strong scientific expertise, making it an ideal partner for advancing neuroscience innovation. The government’s willingness to improve regulatory and reimbursement systems is particularly meaningful.”Edwards identified healthcare, digital, and policy (PA) as key areas for Lundbeck Korea to strengthen. He emphasized the importance of expanding real-world evidence (RWE) and data-driven insights, and leveraging new technologies like artificial intelligence (AI) to communicate more effectively with healthcare professionals. This aligns with Lundbeck's global ‘Focused Innovator’ strategy.The new CEO's mid-to-long-term vision is clear: steadfastly realizing Lundbeck's mission in Korea—‘improving the lives of patients with brain disorders and growing into an agile, high-performing organization through focused innovation in neuroscience.’Edwards stated, “Rather than pursuing abrupt internal changes, we will achieve natural evolution as our pipeline progresses toward commercialization. I hope Lundbeck Korea will grow into an agile, results-driven organization that contributes not only to Korea but also globally.”He concluded, “Lundbeck’s achievements to date have been made possible through collaboration and feedback from many partners and stakeholders. All progress in neuroscience begins with listening to their experiences and insights, and we will continue to engage in close dialogue going forward.”
- Product
- MOHW to unveil list of 4K items subject to price cuts in JAN
- by Kim JiEun Dec 19, 2025 09:09am
- The South Korean government plans to pre-release a list of approximately 4,000 pharmaceutical products subject to price reductions effective January 1, 2026. The price reduction is due to the adjustment of the ceiling price of the actual transaction price.On December 17, an official from the Ministry of Health and Welfare (MOHW) confirmed to DailyPharm that the list of related items and their respective reduction rates will be provided to relevant associations within this week.Earlier this month, the MOHW issued an official notice, announcing 'a temporary allowance for paperwork-only returns when reporting of supply records following the price cuts', to the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KBPMA), the Korea Pharmaceutical Distribution Association, and the Korean Pharmaceutical Association.The notice also informed that the ceiling prices of insurance price tags of approximately 4,000 pharmaceutical products are subject to price reductions effective January 1, 2026.However, concerns have been raised across the industry after the announcement. With less than 15 days remaining until the massive price cut of 4,000 pharmaceutical products takes effect, pharmacies and distributors lacked the specific data, such as exact items, quantities, and reduction percentages, needed to prepare.In response, the MOHW decided to provide the pre-list, including items subject to price cuts due to the actual transaction price ceiling price increase and the reduction rate, to minimize field confusion. Although the price reduction is scheduled to be officially announced on December 24, the MOHW plans to provide the list five days ahead, on December 20.An MOHW official said, "We are aware of the related issue in the distribution industry and pharmacies," and added, "For actual transaction price reduction, the MOHW plans to take administrative response in a way that minimize the field confusion."The official further added, "The affected documents are according to the official notice, but the MOHW will pre-lease the list of affected products to institutions," and added, "It will be announced by this Friday."In 2023, when over 7,600 items were subject to price reductions, the MOHW similarly pre-released the list after the field confusion.At that time, affected organizations, including the Korea KBPMA, the Korea Pharmaceutical Distribution Association, the Korean Pharmaceutical Association, and HIRA, received the pre-lease list files. Pharmacies could verify affected stocks through billing software integration and prepare for the financial impact well in advance.Meanwhile, affected organizations have argued that this pre-release of data to affected parties should be formalized, given the recurring large-scale price reductions.Regarding this issue, the MOHW announced that it is preparing to reform the current actual transaction price-based price reduction system. The ministry acknowledged that the current system imposes an excessive administrative burden on the field relative to its actual impact on health insurance financial savings, primarily because of the vast number of affected items.An MOHW official explained, "In the case of an actual transaction price survey, the number of products subject to investigation is immense, yet the predictability regarding which specific drugs will actually face a price cut is low, which appears to be confusing the field," and added, "For the actual transaction price investigation, we are looking to redesign the entire system of drug pricing and post-management instead of the current method of simple price reductions. We expect this will enhance predictability for the field."
- Company
- 'Cosentyx' reimb changes hidradenitis suppurativa strategy
- by Eo, Yun-Ho Dec 19, 2025 09:08am
- The treatment landscape for hidradenitis suppurativa (HS) in South Korea is at a turning point following approval of 'Cosentyx' for insurance reimbursement.In December 2023, the expanded indication for Novartis Korea's interleukin-17A inhibitor Cosentyx (secukinumab) was approved, making it a new biologic treatment option after approximately 8 years.However, Cosentyx has remained a non-reimbursed drug until now, while Humira has been the only biological agent patients can practically choose.Two years after approval, as of December 1, 2025, the reimbursement criteria for Cosentyx were set to treat adult patients with severe HS. Consequently, a reimbursement option is now available to the domestic HS market in approximately 10 years.The process of expanding reimbursement for Cosentyx has not been easy. The reimbursement application for Cosentyx was submitted soon after receiving indication approval in December 2023. However, the reimbursement review had been delayed due to an external issue. The company voluntarily withdrew the application and resubmitted an expanded reimbursement application in November 2024.Even after that, the review process was challenged by various external issues, including changes to the domestic drug pricing policy and discussions on Most Favored Nations (MFN). Given the evidence, such as large-scale global clinical data, international guideline recommendations, and unmet needs of domestic patients, the company succeeded in expanding reimbursement criteria 1 year after reapplication.Cosentyx is drawing attention for having different mechanisms of action compared with Humira. Whereas Humira blocks Tumor Necrosis Factor-alpha (TNF-α) to inhibit the inflammatory response, Cosentyx works by directly inhibiting IL-17A, which plays a key role in inflammatory immune diseases, thereby inhibiting the release of proinflammatory cytokines and chemokines. This drug reduces abscess and inflammatory lesions in HS.Improved treatment access to a new medicine with a mechanistic difference is meaningful because it not only provides a new option for patients in terms of treatment response conditions and drug tolerance, but also establishes a setting for potentially elaborate personalized treatment plans.Furthermore, it is encouraging that the reimbursement criteria for biological agents were updated during the Cosentyx review. Previously, reimbursement for biological agents in HS was limited to severe patients (Hurley Stage 3). The scope has now expanded to include patients with moderate-to-severe disease (Hurley Stage 2).Another significant change resulting from this expanded reimbursement is improved patient access and a broader range of treatment options. When the Special Case Medical Expense Coverage criteria are applied, the out-of-pocket cost for a single 300mg dose of Cosentyx is KRW 113,482. Cosentyx is administered once weekly for the first month of initiation, followed by dosing every 4 weeks thereafter. Excluding the initial month, patients will pay KRW 113,482 per month during the maintenance phase.In comparison, the out-of-pocket cost for a single 40mg dose of Humira is KRW 28,640, and it is administered every week or every two weeks. The monthly price (4 doses) is approximately KRW 114,560. During the maintenance period, the patient's financial burden is nearly identical for both medications, allowing patients to select and maintain therapies with different mechanisms of action without significant cost disparities.Professor Min Soo Jang, General Affairs Head of the Korean Acne and Rosacea Society (Professor of Dermatology at Kosin University Gospel Hospital), explained, "HS is a difficult disease to cure. There are cases in which the disease does not improve with conventional treatment, or symptoms progressively worsen. Strategic management is possible if a systematic treatment plan is established through biological agents."Professor Jang added, "However, unlike psoriasis or atopic dermatitis, where various biological agents with different mechanisms of action are available, HS treatment options have been limited to a single mechanism. With the expanded reimbursement of Cosentyx, treatment options have widened for patients who had insufficient responses to existing therapies or had to discontinue treatment due to side effects."Meanwhile, in the recently announced 4-year (204-week) extension of the SUNNY study, patients who achieved HiSCR at Week 52 and continued Cosentyx treatment showed a HiSCR achievement rate of 83.2% at Week 204. It was confirmed that the symptom-improvement effect is maintained for up to 4 years after starting treatment.
- Policy
- Moderna’s RSV vaccine gains expedited approval
- by Lee, Tak-Sun Dec 19, 2025 09:08am
- The Ministry of Food and Drug Safety (MFDS) announced on the 18th that it has approved mRESVIA Prefilled Syringe (respiratory syncytial virus [RSV] mRNA vaccine, Moderna Korea) as the first biologic drug to be authorized under the newly implemented ‘New Drug Marketing Authorization and Review Procedures’ implemented this year.The revised New Drug Marketing Authorization and Review Procedures, introduced earlier this year, include expedited review measures such as the formation of dedicated product review teams and prioritizing GMP reviews. These measures were established as follow-up actions to the increase in new drug approval review fees.For the approval of mRESVIA, the MFDS formed a dedicated review team consisting of 18 members, including specialists in new drug evaluation, conducted priority GMP reviews, and held individualized face-to-face meetings before and after the marketing authorization application. Through close communication with the applicant, the MFDS was able to complete the approval process in an expedited manner.The newly approved imported drug, mRESVIA Prefilled Syringe, is indicated for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older, as well as in high-risk individuals aged 18 to under 60 years. It is the first RSV preventive vaccine in Korea approved using an mRNA platform.Respiratory syncytial virus (RSV) is a virus that causes acute respiratory infections with symptoms similar to those of the common cold.Meanwhile, the first small-molecule drug approved under the new fast-track review system was Xcopri Tab (cenobamate) developed by Dong-A ST, which received marketing authorization in November.The MFDS stated that it plans to further enhance the new drug review system through in-depth preliminary assessments, item-by-item parallel reviews, and stage-specific tailored meetings during the new drug approval process. These efforts aim to facilitate rapid market entry of innovative medicines, provide patients with quicker access to treatment options, and support the growth of the biopharmaceutical industry.
