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- 2026-04-28 13:12:39
- Policy
- INN Prescribing Bill may be excluded from April subcommittee
- by Lee, Jeong-Hwan Apr 22, 2026 08:54am
- The Health and Welfare Committee of the National Assembly has decided to hold a legislative subcommittee meeting on the 28th. However, as the ruling and opposition parties have agreed not to table bills under debates, the legislation that would partially mandate International Nonproprietary Name (INN) prescribing by physicians is expected to be excluded from the review agenda.The bill, a national task for the Lee Jae Myung administration and proposed by members of the ruling Democratic Party of Korea, is strongly opposed by the medical community. Furthermore, lawmakers from the main opposition People Power Party maintain a stance of cautious review or outright opposition. Consequently, the likelihood of reaching a bipartisan agreement to include the bill in this month's subcommittee has diminishedIf the bill is excluded this month, after failing to gain a review opportunity last month due to medical community resistance, the INN Prescribing Bill is expected to be considered during the subcommittee meetings held after the June 3 local elections.On the 20th, the executive secretaries of the Health and Welfare Committee agreed to hold the 1st and 2nd Legislative Subcommittees on the 28th. The plan involves reviewing bills under the jurisdiction of the 1st subcommittee in the morning and the 2nd subcommittee in the afternoon. On the following day, the 29th, a Petition Subcommittee will be held, followed by a plenary session to process the bills passed by the subcommittees.The executive secretaries have requested that individual members' offices submit the bills they wish to have reviewed. While the final agenda is determined through bipartisan consultation, the agreement to prioritize 'non-controversial bills' makes it highly likely that the bill mandating INN prescribing for national essential drugs and medicines in unstable supply, a major point of interest in the healthcare sector, will be excluded for the second consecutive month.The proposed amendments to the Medical Service Act and the Pharmaceutical Affairs Act, introduced by Rep. Jang Jong-tae and Rep. Kim Yun of the Democratic Party, would legally mandate physicians to use active ingredient names rather than brand names when prescribing national essential medicines or drugs with unstable supply.While the legislation aims to address social inconveniences, such as patients "pharmacy hopping" due to long-term drug supply instability, the medical community remains adamantly opposed. Kim Taek-Woo, president of the Korea Medical Association (KMA), has repeatedly stated that if the INN Prescribing Bill is tabled, the KMA will gather physicians nationwide for outdoor protests.Since the People Power Party sympathizes with the medical community's opposition, a bipartisan agreement is unlikely even if the Democratic Party requests a review.Furthermore, as this month's subcommittee is condensed into a single day for both the 1st and 2nd subcommittees, unlike the usual practice of dedicating a full day to each, the probability of tabling a highly contentious bill like INN prescribing is even lower.An official from a member's office on the Health and Welfare Committee explained, "We are currently at the stage of selecting bills for review as requested by each office. Since this subcommittee is being held just a month before the June 3 local elections, both parties have agreed to table and process only non-controversial bills."The official added, "The INN prescribing bill is an issue with significant disagreement, including opposition from doctors, making it difficult to include in this subcommittee's agenda. If it is not reviewed this time, it will likely only be possible after the National Assembly is formed in the second half of the year following the local elections."
- Company
- 'Uplizna' to bring a shift to the NMOSD treatment strategy
- by Son, Hyung Min Apr 22, 2026 08:54am
- Tanabe Pharma Korea recently held the UPSTREAM Symposium at Voco Seoul Gangnam to celebrate the launch of NMOSD treatment Uplizna in South Korea.New treatment strategies are emerging for neuromyelitis optica spectrum disorder (NMOSD), a condition where a single relapse can lead to lifelong disability. This shift has been brought about by the introduction of 'Uplizna', a new drug targeting CD19 B cells, for NMOSD treatment in South Korea. Uplizna has been shown to significantly reduce the risk of relapse in AQP4 antibody-positive patients, and medical professionals anticipate that this treatment option will provide patients with a better choice in terms of mechanism and efficacy.Tanabe Pharma Korea recently held the UPSTREAM Symposium at Voco Seoul Gangnam to celebrate the launch of Uplizna (inebilizumab)in South Korea.Professor Ho Jin Kim of the Department of Neurology at the National Cancer Center served as the chairperson. Professor Ki Hoon Kim of the Department of Neurology at Severance Hospital and Professor Jeeyoung Oh of the Department of Neurology at Konkuk University Medical Center delivered lectures titled ▲Optimizing the treatment with inebilizumab after rituximab and ▲inebilizumab in practice: identifying appropriate patients, respectively.Uplizna is a targeted therapy for adult patients with AQP4 antibody-positive NMOSD. It works by targeting and depleting CD19+ B-cells, thereby reducing attacks (relapses) caused by the immune system targeting the optic nerve and spinal cord.The treatment received U.S. FDA approval in 2020 and was authorized in South Korea in 2021. Tanabe Pharma Korea is currently proceeding with the reimbursement listing process for the drug.During the symposium, Professor Ki Hoon Kim began by highlighting B-cells and the AQP4-IgG production pathway as core elements of NMOSD pathophysiology.The professor explained, "Plasma cells are directly linked to the clinical deterioration of NMOSD. Unlike rituximab, which targets only CD20, Uplizna depletes cells up to the pre-CD19 stage, allowing for an approach closer to the underlying cause of the disease."NMOSD is a rare autoimmune disease characterized by unpredictable, repeated relapses of optic neuritis and myelitis, leading to severe disabilities such as eye pain, blindness, and paraplegia. Approximately seven out of ten NMOSD patients are AQP4 antibody-positive; the formation of these antibodies activates the complement system, which can cause necrosis in the optic nerve and spinal cord.Notably, 80–90% of patients experience recurrent relapses, thus even a single event can result in fatal outcomes. These symptoms are often irreversible and difficult to recover from, necessitating rapid acute-phase treatment fully.Previously, NMOSD relapse relied on high-dose steroids or immunosuppressants to suppress symptoms or used rituximab or 'tocilizumab (product name: Actemra)' to prevent relapses. However, as the relapse suppression effects of these treatments were limited, there was a high demand for new options.Rituximab' clinical limitations have been pointed out. These include non-unified administration protocols, varying B-cell depletion and relapse risks based on FCGR3A genotypes, and high rates of infusion-related reactions (IRR) during the first administration. In contrast, evidence was presented that Uplizna is easy to manage with twice-yearly dosing, reduces the risk of relapse by more than 70% in clinical trials, and cuts the rate of worsening on the Expanded Disability Status Scale (EDSS) by more than half. Professor Kim summarized, "Uplizna is an option that can supplement the structural limitations for patients who do not respond to rituximab."In the second session, Professor Oh focused on the timing of switching therapies, which is a challenge in NMOSD treatment.Professor Oh emphasized, "Defining treatment failure based solely on clear relapses may cause us to miss patients." She presented various clinical patterns, including partial responses, incomplete recovery after severe relapses, and switching due to side effects or infections.Professor Oh also pointed out that due to strict domestic reimbursement criteria, some patients with "disability creep," where disability accumulates slowly without clear relapses, may miss the window for adjusting their treatment strategy.Based on actual patient cases, Professor Oh identified characteristics of patient groups requiring a switch from rituximab to Uplizna.The characteristics include ▲rapid repopulation of CD19+ B-cells, ▲incomplete response due to genotype influence, and ▲difficulty maintaining treatment due to infection burdens such as pneumonia.Professor Oh also highlighted data showing the sustained efficacy of Uplizna.The N-MOmentum study, which served as the basis for approval, was a 28-week randomized, placebo-controlled trial that faithfully reflected the NMOSD patient population in real-world clinical settings by including diverse racial and ethnic groups.In the trial, 89% of the Uplizna group remained relapse-free for 28 weeks, compared to only 58% of the placebo group.Long-term data also showed sustained efficacy, with an annualized relapse rate (ARR) of 0.03 for patients treated with Uplizna for at least 2.5 years, significantly lower than the approximately 1.0 ARR in the placebo group.However, because the open-label period (OLP) was non-blinded and uncontrolled, the results might appear more positive due to patient dropout among those with poor prognoses.Professor Oh assessed that "Uplizna is an option that is not merely as a substitute, but the one that ensures both efficacy and safety when a mechanistic switch is required."Professor Kim concluded, "Because NMOSD is a disease where a single minor relapse can lead to lifelong disability, establishing an initial strategy and determining the appropriate timing for a switch is paramount," adding, "This symposium was meaningful for refining our understanding of mechanism-based treatment and discussing customized decisions for each patient. The introduction of Uplizna will serve as an opportunity to advance NMOSD treatment strategies to the next level."
- InterView
- [Reporter’s View] Rapid support for essential medicines put to the test
- by Jung, Heung-Jun Apr 22, 2026 08:54am
- As the supply of essential medicines, such as basic IV solutions, is being affected by the aftermath of the Middle East war, attention is focusing on the government’s flexible drug price support measures.Since the outbreak of the Middle East situation, the government has been pouring out multifaceted measures such as priority supply of naphtha, strengthened monitoring of pharmaceutical supply and demand, and prohibition of hoarding.While the immediate focus is on supply management, follow-up support measures are also needed. This is because the burden on pharmaceutical companies producing essential drugs is gradually increasing and could potentially lead to supply instability.In particular, intravenous solutions, where raw materials account for a large portion of production costs, are bearing the brunt of the impact. According to industry sources, the prices of raw materials, which make up about 30–40% of costs, are rising sharply due to naphtha supply instability.Because it is impossible to know when the Middle East situation will stabilize, pharmaceutical companies producing IV solutions are concerned about mounting losses.While this varies by product type, basic IV solutions already have low drug prices. This means that the losses pharmaceutical companies must absorb due to rising costs could become an even greater burden.The government is not sitting idly by. The Ministry of Health and Welfare is strengthening supply and demand monitoring in collaboration with the Health Insurance Review and Assessment Service (HIRA) and the National Health Insurance Service (NHIS). Based on this, it appears they will also review the necessity of raising drug prices.However, the Ministry appears to be exercising caution regarding how much of the situation is truly attributable to the Middle East war. This is because it is necessary to distinguish between cost increases caused by force majeure supply chain shocks and routine price increases caused by other factors.While it is positive that the government is considering supporting production through drug price hikes, the issues lie in implementation speed and flexibility.If the process proceeds via the existing drug price adjustment mechanism, there could be a delay of up to several months between review and actual implementation. This has the limitation of being too slow to defend against cost shocks occurring in real time.Because the government is monitoring price and supply fluctuations of petrochemical raw materials such as naphtha, it could also use this as a basis for drug price support.For example, if price increases and supply instability are expected for the next three months, a flexible support mechanism could be implemented that applies price increases only during that specific period. The rate of increase could be determined according to the degree to which subsidiary raw material prices have affected costs.On the 14th, the Ministry of Economy and Finance and the Ministry of Trade, Industry, and Energy Free Trade Zones announced the “Regulation on Prohibition of Hoarding and Emergency Supply-Demand Adjustment of Petrochemical Raw Materials,” which allows the government to issue supply adjustment orders and provides for compensation for losses incurred in such cases. This reflects the judgment that active government intervention is necessary depending on the severity of the situation.The Ministry of Health and Welfare recently finalized a reform plan containing measures for “operating a supply-friendly drug pricing system for essential medicines.” The main thrust of the plan is to strengthen proactive support to ensure a stable supply.The current situation in the Middle East serves as a test bed for applying such a government policy direction. Along with strengthening supply and demand monitoring, there is a need to consider flexible drug pricing support measures to ensure the stable production of essential medicines.
- Policy
- Government mobilizes full effort to stabilize medical product supply
- by Kang, Shin-Kook Apr 22, 2026 08:54am
- The government is launching an all-out response, including additional syringe production and increases in fees for treatment materials, in order to resolve the supply instability of pharmaceuticals and medical devices caused by the prolonged war in the Middle East.The Ministry of Health and Welfare (Minister Eun-kyeong Jeong) held the “4th Meeting of Health and Medical Organizations in Response to the War in the Middle East” on the morning of the 21st at Conference House Dalgaebi in Jung-gu, Seoul, together with 12 health and medical organizations and relevant ministries, and discussed medical product monitoring results and future action plans.At present, production volumes of major medical products such as syringes, needles, medicine pouches, and syrup bottles are not much different from the previous year, but measures are being implemented to preemptively block concerns over supply instability.First, regarding syringes, which had raised significant concerns about supply instability, Korea Vaccine has agreed to produce an additional 500,000 units per week for seven weeks, totaling 3.5 million units, through special overtime work. The units produced in this manner will be prioritized for supply to hemodialysis clinics, pediatric and adolescent medicine clinics, and obstetric medical institutions via the Korean Medical Association’s ‘Syringe Hotline,’ and some will be distributed to medical institutions through online stores.Medicine pouches and syrup bottles are likewise not in short supply in the first quarter, but the government plans to continue supporting manufacturers so that raw materials can be supplied to them on a priority basis.Economic support measures have also been put in place to alleviate the cost burden on companies caused by the recent rise in exchange rates.The Ministry of Health and Welfare has decided to increase the average reimbursed health insurance fee by 2% for approximately 27,000 separately billed medical supplies to compensate for the rise in prices of imported raw materials.At the same time, it will respond strictly to acts that disrupt the distribution order. Beginning this week, the Ministry of Food and Drug Safety is deploying a 70-member ‘special syringe and needle crackdown team’ to intensively inspect hoarding and other illegal activities. It plans to take severe measures against any confirmed violations.Regulatory relief measures to alleviate on-site difficulties are also being pursued. The Ministry of Climate Change, Energy and Environment, and the Ministry of Health and Welfare are reviewing a plan to temporarily extend the disposal cycle for general medical waste, on the premise that management will be strengthened so that no infection risk occurs.Minister Eun-kyeong Jeong said, “Production volumes of key items such as syringes are being managed stably at last year’s levels. We will do our utmost to ensure that necessary medical services are provided to the public without disruption through close monitoring.”
- Company
- Dupixent is shifting the atopic dermatitis treatment
- by Hwang, byoung woo Apr 22, 2026 08:53am
- Presentation by Jung Won Shin, Medical Lead at Sanofi, during the Dupixent media sessionAtopic dermatitis treatment is expanding, moving from simple symptom relief toward changing the disease progression.As treatment approaches shift toward mechanism-centered strategies following the introduction of biologics, the combination of long-term efficacy demonstrated in real-world data and early treatment strategies for children is prompting discussions of the possibility of 'disease modification.'On the 21st, Sanofi held a media session titled 'Dupixent, Rewriting the Standards of Atopic Dermatitis Treatment' to share updates on the treatment paradigm and its clinical significance.From Symptom Relief to Mechanistic Treatment…Changes in Atopic Dermatitis ApproachesAtopic dermatitis is increasingly recognized not just as a disease limited to skin symptoms, but as a chronic inflammatory condition that affects overall sleep, mental health, and comorbidities.Jung Won Shin, Medical Lead at Sanofi, explained, "Atopic dermatitis is a disease accompanied by various disease burdens in addition to visible skin symptoms," and added, "A long-term management of the disease is crucial."In particular, the emphasis was placed on the fact that the disease affects the patient's entire life, including sleep disorders, psychological withdrawal, and restrictions on social life, as well as an increased risk of infection due to skin barrier damage.These disease characteristics are leading to changes in treatment goals. In the past, the focus was on short-term symptom relief using local steroids or systemic immunosuppressants. However, the current view is that treatment strategies are moving toward targeting the underlying inflammation of the disease.Regarding this, Shin stated, "In the last 10 years, atopic dermatitis treatment has significantly changed, centering on mechanism-based targeted therapy."In this process, Dupixent was presented as a representative case leading the expansion of treatment options as a biologic that simultaneously blocks the IL-4 and IL-13 pathways.Efficacy Confirmed by Long-term Data…Strengthening Persistence·RWE EvidenceLong-term data collected in clinical settings were presented as key evidence supporting the treatment's persistence and efficacy.According to Professor Yonghyun Jang of the Department of Dermatology at Kyungpook National University Hospital, who was in charge of the presentation, an analysis of domestic patient data showed a drug persistence rate of 80.4% over 4 years.Furthermore, the EASI 75 achievement rate was 91.5%, and the EASI 90 achievement rate was approximately 44.1%, confirming that meaningful treatment responses are maintained in patients with moderate-to-severe conditions. These effects have been consistently demonstrated in actual clinical settings through global, long-term follow-up studies such as PROSE, GLOBOSTAD, and RELIEVE-AD.Professor Jang stated, "EASI, pruritus (NRS), and quality of life (DLQI) indicators all show improvement from a relatively early point after starting treatment. Significant changes in indicators appear around the three-month mark."Presentation by Professor Yonghyun Jang of the Department of Dermatology at Kyungpook National University HospitalProfessor Jang explained that these improvement effects do not end with short-term responses but tend to remain stable during long-term follow-up.Similar trends were confirmed regarding Patient-Reported Outcome (PRO) indicators.Professor Jang stated, "Meaningful improvements were demonstrated not only in objective indicators of skin lesions but also in the itching and quality of life indicators perceived by the patient. In particular, the improvement in the quality of life is characterized by being confirmed from a relatively early stage."Professor Jang added, "In the long-term follow-up data, new safety issues were limited, and there were not many cases leading to treatment discontinuation in clinical practice."Dupixent's RWE long-term follow-up data (6 years, RELIEVE-AD Registry)Attention to Early Childhood Treatment…Possibility of Disease ModificationIn particular, the media session that day presented early treatment strategies in pediatric patients and the possibility of disease modification as key points.Professor Jang said, "Atopic dermatitis is highly likely to progress along this path if inflammation is not sufficiently controlled at an early age and exacerbations are repeated," and added, "Managing the inflammatory state stably in the early stages of the disease is important to lower the long-term disease burden."Professor Jang also highlighted the role of Dupixent. This means that there is a possibility of a treatment approach that changes the natural course of the disease beyond simple symptom control.Professor Yonghyun Jang of the Department of Dermatology at Kyungpook National University HospitalAccording to the presentation, long-term follow-up studies confirmed a tendency for the disease-controlled state to be maintained after Dupixent treatment, and improvements were reported to persist in the ADCT indicator, which assesses patients' self-reported disease state.In addition, improvements continued in major symptoms, such as itching and sleep problems, which served as indicators directly linked to changes in the patient's quality of life.Furthermore, it was reported that Dupixent treatment reduced the risk of new allergies by approximately 34%, the risk of asthma by approximately 40%, and the risk of allergic rhinitis by approximately 31%.Regarding this, Professor Jang stated, "If treatment is applied early in severe patients, there is a possibility of changing the course of the disease itself in some patients. This can be seen as a treatment approach that can change long-term disease progression beyond simply controlling symptoms."During the Q&A session, it was mentioned that there are no concerns regarding long-term administration safety when administering Dupixent from childhood.Professor Jang said, "Atopic dermatitis can progress to a persistent disease once it exceeds a certain level of inflammatory state. An approach that blocks this progression through early treatment is important."Professor Jang also noted, "It is reported that the effect reappears even if Dupixent is re-administered after discontinuation. Resistance due to long-term use is not a significant concern."
- Company
- Will CDK4/6 inhibitors be reimbursed for early breast cancer?
- by Son, Hyung Min Apr 22, 2026 08:53am
- Despite significant improvements in survival rates for early-stage breast cancer patients, concerns have been raised about how treatment access to reduce long-term recurrence risk remains limited.In particular, as the clinical value of CDK4/6 inhibitors has been proven in patients at high risk of recurrence, the treatment strategy is clearly shifting beyond simple treatment toward recurrence prevention, yet it has become increasingly clear that reimbursement is failing to keep pace with these developments.On the 21st, Rep. Mi-hwa Seo of the People Power Party hosted a policy forum titled “The Era of 300,000 Female Breast Cancer Patients: Current Status and Challenges in Recurrence Management,” and intensively discussed recurrence management and treatment access issues for patients with early breast cancer.On the 21st, experts gathered at the National Assembly Members’ Office Building to discuss measures for managing recurrence in early breast cancer.Early-stage breast cancer refers to a condition where cancer cells have not spread beyond the axillary lymph nodes, and accounts for approximately 95% of all breast cancer patients.The 5-year survival rate is high, at 96.6% for Stage 1 and 91.8% for Stage 2, but the problem raised is that, regardless of survival rates, the risk of recurrence remains considerable. In particular, for hormone receptor-positive (HR+) patients, recurrence can continue beyond 5 years after diagnosis and even up to 20 years, underscoring the need for long-term management.Over the past 20 years, treatment strategies for early breast cancer have centered on surgery, radiation therapy, chemotherapy, and endocrine therapy. However, limitations regarding the inability to sufficiently reduce recurrence rates have been consistently raised.Professor Hyun-jae Yoo, Sogang UniversityIn response, a research team led by Professor Hyun-jae Yoo at Sogang University conducted a study to quantitatively analyze the socioeconomic burden on early-stage breast cancer patients.The study was conducted using a combination of surveys and expert advisory interviews with 150 patients aged 19 to 60 who had stage 1 to 3 breast cancer.The analysis revealed that patients who experienced recurrence incurred approximately KRW 29 million more in total economic losses compared to those who did not.In particular, indirect medical costs were found to increase by more than KRW 13.3 million on average, and the burden of indirect costs in recurrent patients was confirmed to be about 1.8 times higher.Professor Yoo explained, “Breast cancer is not a disease that simply ends with treatment, but a disease that affects overall quality of life and social roles after treatment. A treatment strategy that prevents recurrence has important meaning not only for the individual but also from the perspective of social cost.”Need for treatment centered on high-risk recurrence groups… “unmet need remains”Given that the risk of recurrence does not completely disappear even in early breast cancer, there is a growing consensus that more aggressive treatment strategies are needed, particularly for high-risk groups.In particular, it has been pointed out that in patient groups with a high risk of recurrence due to lymph node metastasis or tumor size, such as some late Stage 2 or Stage 3 patients, existing treatment alone has limitations.In this field, CDK4/6 inhibitor-based therapies are emerging as a new alternative. Novartis’ ‘Kisqali (ribociclib)’ and Lilly’s ‘Verzenio (abemaciclib)’ have demonstrated their efficacy in reducing the risk of recurrence through clinical trials.Professor Ji-hyun Kim, Seoul National University Bundang HospitalProfessor Ji-hyun Kim of Seoul National University Bundang Hospital emphasized, “CDK4/6 inhibitors are treatments whose efficacy in reducing recurrence and clinical utility have already been confirmed through large-scale clinical trials. They should be considered as a new standard of care for high-risk patients with early-stage breast cancer.”The problem is that these treatments are not being fully utilized in actual clinical practice.Although CDK4/6 inhibitors have been approved in Korea, reimbursement is not applied in adjuvant therapy for early breast cancer, forcing patients to bear the full cost of these expensive drugs.In contrast, Verzenio is already covered by national health insurance in major countries such as the United Kingdom, Australia, Canada, France, Germany, Italy, China, and Singapore, ensuring access to treatment.Professor Ji-hyun Kim added, “From the perspective of an individual patient, one would want to try every possible treatment, but in terms of national finances, there is the difficulty of balancing resources across various diseases. There needs to be a social discussion on how to rate the value of therapies that prevent recurrence in advance.”“Financial resources and equity are variables”… attention on government’s judgment over reimbursement criteriaIn the panel discussion that followed, policy issues surrounding access to new drugs for early breast cancer were intensively discussed.Professor Seong-bae Kim of Asan Medical Center in Seoul, who moderated the discussion, emphasized, “While triple-negative breast cancer is generally known to be more aggressive, some hormone receptor-positive breast cancers also present a higher risk of recurrence. It is important to identify high-risk groups and apply appropriate treatments.”He added, “The efficacy of CDK4/6 inhibitors has already been clinically proven. The issue lies in reaching a social consensus on how to apply this in actual clinical practice and which patient groups should be prioritized within limited financial resources.”Professor In-Hae Park of Korea University Guro Hospital said, “Even in high-risk patients, there are cases in which it is difficult to actively explain or recommend treatment because of the economic burden. The reality itself, in which treatment strategy must be adjusted in consideration of the patient’s financial situation, places a burden on medical staff as well.”The panelists also pointed out that the threshold for reimbursement has risen as the weight of financial impact assessments has increased in recent Cancer Disease Deliberation Committee meetings.A view of the panel discussionYoon-ho Eo, a reporter for Daily Pharm, stated, “Currently, the results of reimbursement reviews are structured such that only the decision to approve or deny coverage is disclosed, lacking transparency regarding the basis for the judgment. There is a need to strengthen the transparency and flexibility of the evaluation process.”The government maintains a cautious stance but intends to continue related discussions.Min-jung Kim, an official at the Division of Pharmaceutical Benefits at the Ministry of Health and Welfare, stated, “Reimbursement applications for Verzenio and Kisqali have been submitted, and discussions are expected to proceed in the Cancer Disease Deliberation Committee within the first half of the year. We plan to conduct a fair review by comprehensively considering clinical utility, patient access, and the impact on National Health Insurance finances.”She continued, “In line with the recent trend toward strengthening coverage for anticancer drugs, the scope of reimbursement has been continuously expanding. Since equity must be maintained within limited financial resources, careful review of the patient group setting and the scope of application is necessary.”The Health Insurance Review and Assessment Service presented a similar position.Ae-ran Park, Director of the Pharmaceutical Benefits Standards Division at HIRA, explained, “We are fully aware of the clinical necessity and field demands for preventing early recurrence of breast cancer. The demand to apply follow-up treatments at an early stage is a trend common not only in breast cancer but across various cancer types.”Park added, “While expanding treatment accessibility based on clinical utility is important, we must also consider the balance with the sustainability of the National Health Insurance finances. Setting the criteria for which patient groups should be prioritized is the key task.”
- Policy
- Xtandi generics signal June showdown as patent expiry nears
- by Lee, Tak-Sun Apr 21, 2026 07:33am
- Astellas’ newly launched ‘Xtandi Tab’GL Pharma has thrown its hat into the ring for the generic market of Astellas Pharma Korea’s blockbuster prostate cancer treatment, ‘Xtandi (enzalutamide).’ With the compound patent set to expire in June, domestic pharmaceutical companies are securing approvals one after another, and fierce competition is expected in the second half of the year to gain market leadership.GL Pharma’s ‘Proenza’ approved… expands generic lineupAccording to industry sources on the 20th, the Ministry of Food and Drug Safety (MFDS) granted marketing authorization for GL Pharma’s ‘Proenza Soft Cap 40mg.’ This product is manufactured under a contract manufacturing (CMO) arrangement with Cosmax Pharma.With this approval, the number of domestic companies holding approvals for Xtandi generics has increased to include GL Pharma, joining existing holders Alvogen Korea (Anamide), Daewon Pharmaceutical (Enzadex), Hanall Biopharma (Enzaluta), Menarini Korea (Enzal-X), and Hanmi Pharmaceutical (Enzaron).In particular, following Hanmi Pharmaceutical’s approval last month for the first domestically manufactured product, GL Pharma has also secured a domestically produced product, improving supply stability.AI-generated imageFormulation patent through 2033 also avoided… launch barriers eliminatedThe patent barriers, which had been the biggest obstacle for generic companies, have in effect all been removed. Xtandi had been protected mainly by two patents.The compound patent (diaryl hydantoin compound) expires on June 27, 2026. Generic drugs are expected to enter the market starting at this point.The formulation patent (enzalutamide formulation) was scheduled to expire in September 2033. However, five domestic companies, including GL Pharma, Hanmi Pharmaceutical, Chong Kun Dang, JW Pharmaceutical, and Alvogen Korea, recently succeeded in circumventing it by securing a favorable ruling after obtaining favorable decisions in passive scope confirmation trials.As a result, domestic companies have fully secured the legal basis to launch generics early, from June 28.Astellas’ last stand “tablet conversion”… can it defend the market?The defense strategy of the originator company, Astellas Pharma Korea, is no less formidable. Astellas moved to defend the market by abruptly listing ‘Xtandi Tab (40 mg, 80 mg)’ for reimbursement this month, immediately before generic launch, which improves ease of administration.Compared to the existing 40 mg soft capsule, the 40mg tablet version is about half the size, and with the addition of the 80 mg high-dose product, the daily dosage has also been reduced. Consequently, the medication burden of patients who had to take four 40 mg capsules per day is expected to be significantly eased.The price for the 40mg product remains unchanged at KRW 14,167 per tablet, the same as the existing soft capsules, while the 80mg product is priced at KRW 21,251 per tablet. Notably, for the 80mg product, the monthly medication cost (based on 56 tablets) is approximately 25% lower than that of the existing 40mg capsules (112 capsules), which is expected to reduce the financial burden on patients.Astellas’ strategy is to use the tablet formulation to penetrate the generic drug market, which currently consists solely of capsule formulations.According to pharmaceutical market research firm UBIST, Xtandi recorded KRW 38 billion in sales last year, up 26% from KRW 30.2 billion the previous year. Industry attention is focused on whether Astellas can defend the market with the new tablet product.A pharmaceutical industry source said, “With GL Pharma joining the fray, the scale of generics to be launched in line with the June compound patent expiry has grown even larger. Going forward, who secures pricing competitiveness will be one of the decisive factors.”
- Company
- Merz Aesthetics Korea successfully holds ‘Confidence To Be Conference’
- by Hwang, byoung woo Apr 21, 2026 07:33am
- Scene from the ‘Confidence To Be Conference 2026’ eventMerz Aesthetics Korea announced on the 20th that it held the “Confidence To Be Conference 2026.”The event was held on the 16th at Dongdaemun Design Plaza in Seoul under the theme “Finding the answer in being myself,” and was planned as part of the company’s global consumer ESG campaign “Confidence To Be.”The event was also based on the company’s mission, “Look Better, Feel Better, Live Better,” helping all people live with greater confidence through the journey of finding a better self.The event highlighted the correlation between medical aesthetics and confidence, drawing on data from the global study “Pillars of Confidence,” which surveyed 15,000 people across 15 countries, as well as big-data trends.Through this, the company presented expanded value that extends beyond individual physical transformation to include enhanced social confidence and improved quality of life.Experts from various fields then participated to share their experiences and philosophies of living a confident life.Strength coach Eunseo Kim emphasized the importance of self-understanding and attitude and conducted practical exercises on site, while Mickey Kim introduced his experience of career transition and mindset for change. Choreographer Monica highlighted the importance of making choices at life’s turning points and living proactively.In addition, the event addressed the importance of proper self-perception in the social media environment and presented a healthy approach to medical aesthetics, including consultations with medical professionals, long-term planning, and the sharing of procedure history.Su Yeon Yu, General Manager of Merz Aesthetics Korea, said, “Medical aesthetics is not about standardized beauty, but a process of enhancing quality of life through confidence that is true to oneself. We will continue to expand our positive impact.”
- Company
- "Companion diagnostics…ovarian cancer diagnostic paradigm shift"
- by Hwang, byoung woo Apr 21, 2026 07:33am
- A shift in the treatment paradigm for platinum-resistant ovarian cancer, a field with historically limited options, is anticipated following the arrival of antibody-drug conjugate (ADC) therapies.Notably, the introduction of new treatments has highlighted the growing importance of companion diagnostics in determining 'which patients should receive the therapy?'Daily Pharm met with Min Ae Baek, Manager of the Pathology Diagnostics Division at Roche Diagnostics Korea, to discuss the significance of companion diagnostics in ovarian cancer, practical clinical application, and the substantial value to patients.Platinum-resistant ovarian cancer, a disease without alternative options…addressing treatments and diagnostics altogetherOvarian cancer is classified as a high-risk malignancy due to the difficulty of early detection and high recurrence rates. Most patients are diagnosed at advanced stages and frequently experience recurrence even after standard therapy. Platinum-resistant ovarian cancer, which recurs within six months of platinum-based chemotherapy, poses a particularly restrictive environment due to low response rates to conventional therapies and poor prognosis.Manager of the Pathology Diagnostics Division at Roche Diagnostics KoreaBaek identified the 'treatment void' as the primary unmet need in platinum-resistant ovarian cancer. Baek explained, "Reaching the platinum-resistant stage effectively leaves patients with no viable alternatives. As response rates to existing drugs decrease and life expectancy drops to approximately one year, both patients and guardians find themselves in a desperate situation," she explained.Baek said, "Most patients with ovarian cancer are diagnosed at stage 3-4, and in many cases, patients experience relapses; the majority of patients reach these stages."The recently introduced targeted therapy, Elahere (mirvetuximab soravtansine), and its companion diagnostic are viewed as pivotal elements that could alter the current treatment landscape.Baek said, "The emergence of a new option in an area where alternatives were non-existent, coupled with a test to screen for patients who can benefit from it, represents a significant evolution."Treatment success is dependent on patient selection…the significance of companion diagnosticsThe oncology paradigm is rapidly evolving. Previously, treatment relied on broad application. Currently, it is moving toward precision medicine based on specific biomarkers. In this transition, companion diagnostics function as the starting point of the treatment strategy."The core value of companion diagnostics lies in selecting the appropriate patient group, thereby simultaneously enhancing treatment efficiency and safety," Baek stated. "Identifying suitable patients through testing reduces the burden of side effects and costs associated with unnecessary treatments while increasing the efficiency of the clinical decision-making process."Baek's view is that these trajectories not only help medical professionals to make decisions but also directly impact patients.At the center of this shift is the biomarker folate receptor alpha (FRα). As a protein highly expressed on ovarian cancer cells, FRα has gained clinical utility as a target for ADC therapies. Baek explained, "Ovarian cancers require folate for proliferation and overexpress these receptors to absorb folate for proliferation. This characteristic is utilized for targeted anticancer strategies."The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay plays a crucial role here. This immunohistochemistry (IHC)-based companion diagnostic assesses FRα expression in tumor tissue to identify eligible patients. Baek mentioned, "This approach is a dye-based assay, where FRα protein expression is checked, and pathologists confirm these under a microscope," and "It does not simply check for presence but evaluates expression levels against criteria to determine if treatment is applicable."The value of diagnostic-led therapy has been substantiated in clinical studies such as the Phase 2 SORAYA and Phase 3 MIRASOL trials. Baek stated, "The SORAYA study provided initial evidence showing a meaningful objective response rate for Elahere monotherapy," and added, "In the MIRASOL study, superior therapeutic effects compared to conventional chemotherapy were confirmed when treatment was applied after selecting patients with high FRα expression.Specifically, in clinical trials, Elahere has been shown to improve major clinical indicators compared to existing treatments. Significant improvements in progression-free survival and objective response rate have been reported, along with a reduction in the risk of disease progression or death.Current guidelines from the Korean Society of Gynecologic Oncology (KSGO) already recommend Elahere for FRα-positive platinum-resistant ovarian cancer with the highest level of evidence (Level I) and recommendation grade (Grade A).Domestic launch imminent in May..."Will help in deciding treatment options"In Korea, the treatment environment based on companion diagnostics is also entering the full-scale introduction stage.Both Elahere and Roche Diagnostics Korea's companion diagnostic (VENTANA FOLR1 (FOLR1-2.1) RxDx Assay) have already received approval from the Ministry of Food and Drug Safety, and clinical use is expected once test supplies begin.Baek said, "To prescribe medicines, assays must be available. Assays will be supplied in Korea starting this May," and added, "Pathological divisions in Korea already have an established platform to deliver these assays. The view is that it will be effectively implemented, considering the established diagnostics infrastructure."Baek also mentioned, "There have been continuous inquiries from the field regarding the ability to provide new treatment options to patients with platinum-resistant ovarian cancer," and conveyed, "As it is a test that already has high awareness among medical staff and has been awaited for introduction, expectations are also high from patients."As the treatment and companion diagnostic are ahead of their launch, there is an opinion in the clinical field that it is necessary to preemptively establish treatment plans by performing the FRα test during the initial diagnosis stage rather than at the stage of treatment use.Regarding this, Baek projected that if the test is conducted within the approved criteria, it could help consider future treatment options.Baek stated, "The current approval criteria allow for testing on specimens from patients diagnosed with high-grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer," and noted, "Checking each patient's information in advance could assist medical staff in establishing treatment plans."Ultimately, as the expansion of companion diagnostics leads beyond simple technology introduction to a change in the treatment structure, the role of Roche Diagnostics Korea is also expanding.The company is focusing on more than just supplying testing products. It is building an environment where pathology medical staff can perform tests reliably and support the smooth implementation of companion diagnostic-based treatment.Baek added, "As companion diagnostics are a critical area directly linked to treatment, it is important to ensure that patients are appropriately selected through standardized tests in a stable environment and that the results lead to treatment," and added, "We will continue to prepare the foundation so that companion diagnostics can be implemented in the medical field in line with the trend of emerging new biomarkers and treatments."
- Policy
- HER2-mutated NSCLC treatment 'Hyrnuo Tab' approved
- by Lee, Tak-Sun Apr 21, 2026 07:33am
- The Ministry of Food and Drug Safety (MFDS, Minister Yu-Kyoung Oh) announced that it has approved the imported orphan drug 'Hyrnuo Tab (sevabertinib, Bayer Korea)' on the 20th.Hyrnuo Tab is a medication used to treat patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations and have previously received systemic therapy.HER2 (Human Epidermal Growth Factor Receptor 2) is a protein involved in the regulation of cell growth. When a mutation occurs in the HER2 TKD (Tyrosine Kinase Domain), downstream signaling pathways involved in cell proliferation and survival are excessively activated, promoting the growth and survival of cancer cells.This drug is an oral reversible tyrosine kinase inhibitor (TKI) targeting HER2, exhibiting anticancer effects by inhibiting the growth of cancer cells expressing mutated HER2.The MFDS explained that it designated Hyrnuo Tab as the 43rd product under the 'Global Innovative Product on Fast Track (GIFT) support system' and conducted an expedited review to ensure its rapid introduction into the medical field.The GIFT system is a program designed to quickly review global innovative medical products with outstanding innovation in treatments for life-threatening, serious, or rare diseases.A MFDS official stated, "We will continue to put our efforts into ensuring that treatments with sufficiently confirmed safety and efficacy are reviewed and approved promptly based on our regulatory science expertise, thereby contributing to expanding treatment opportunities for patients."
