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- 2026-04-03 19:58:43
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- Will companies pass Korea due to Trump’s drug price reform?
- by Moon, sung-ho Aug 26, 2025 06:05am
- Since Trump took office, the US has designated the pharmaceutical industry as its core strategic industry and is working to reshape the industry with the US at its center. The goal is to significantly lower drug prices in the U.S., the world's largest pharmaceutical market. However, the “Most-Favored-Nation Pricing (MFN)” policy recently announced by the U.S. health authorities is causing tension not only in Korea’s pharmaceutical industry but also in clinical settings. #This is because there is a possibility that global pharmaceutical companies may reconsider their plans to launch new drugs in Korea due to the U.S. MFN policy. The clinical field is also closely monitoring the future direction of U.S. policy, as it could affect patients' access to new drugs. In May, U.S. President Trump signed an executive order to promote the MFN policy. The MFN policy aims to lower the prices of prescription drugs in the United States to the lowest level among major developed countries. The target drugs include high-priced treatments (such as anticancer drugs and immunotherapy drugs) with the highest annual expenditures under Medicare Part B, the U.S. health insurance program. The plan is to determine U.S. drug prices by referencing the lowest drug prices among OECD countries with per capita GDP (GDP) of 60% or more of the U.S. level. This aims to alleviate the burden of drug prices in the U.S. while preventing other countries from supplying drugs at prices significantly lower than those in the U.S. On the 31st of last month, President Trump went so far as to give 17 multinational pharmaceutical companies a “60-day deadline” to lower drug prices in the United States to overseas levels. Specifically, the companies include AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, BMS, Eli Lilly, Merck Germany (EMD Serono), Genentech, Gilead, GSK, Johnson & Johnson, Merck (MSD), Novartis, Novo Nordisk, Pfizer, Regeneron, and Sanofi. The multinational pharmaceutical companies responded immediately to the pressure. Eli Lilly has decided to raise the price of its obesity treatment, Mounjaro (tirzepatide), in the UK. Specifically, the price of Mounjaro in the UK will be increased by up to 170%. The private price of Mounjaro will rise from the current GBP 92-122 (approximately KRW 173,000-229,000) per month to GBP 133-330 (approximately KRW 249,000-620,000). At the same time, insulin prices in the US will be reduced by 70%, with a cap on patient copayments set at USD 35 per month. Novo Nordisk has also decided to lower the US price of its diabetes treatment Ozempic (semaglutide). The monthly price will be reduced from USD 1,000 (approximately KRW 1.39 million) to USD 499 (approximately KRW 620,000). Other multinational pharmaceutical companies may also follow, lowering their prices in the US and raising prices in other countries. With the US drug price reduction policy becoming a reality, the domestic pharmaceutical industry is also reacting sensitively. This is because the launch of new drugs by global pharmaceutical companies could be linked to this policy. The most notable point is whether South Korea will be included as a reference country. Given that the policy states that “the U.S. price will be determined by referring to the lowest drug price among OECD countries with a per capita GDP of 60% or more of the U.S.,” the prevailing opinion is that South Korea and Japan will be excluded from the reference countries. However, there are predictions that South Korea could become an MFN target country if PPP (purchasing power parity-based GDP) is applied, leading to heightened tension among multinational pharmaceutical companies considering new drug launches in Korea. With no specific details on the application of reference countries or other measures announced, tension is growing across the entire domestic pharmaceutical industry. The Ministry of Health and Welfare and the Health Insurance Review and Assessement Service are closely monitoring the U.S. government's policy announcements and considering future response strategies. A KRPIA official stated, “The U.S. government has not disclosed specific application methods, such as reference countries, for its MFN drug pricing policy, so the situation is currently uncertain. If South Korea is used as an international reference price standard, it could affect not only the sustainability of domestic drug pricing policies but also patients' access to treatment.” Although not yet evident on the surface, there are opinions within multinational pharmaceutical companies that they have begun to hesitate about launching new drugs in Korea. This is because it would be difficult to publicly announce a delay in the launch of new drugs in Korea due to the uncertainty surrounding the MFN policy. A representative from a multinational pharmaceutical company stated, “There are opinions that a specific company has put new drug approval negotiations on hold at the headquarters level, but this has not been publicly disclosed yet. However, there is concern that the global market views the Korean pharmaceutical market as taking a fairly conservative approach to pricing innovative new drugs.” As a result, the U.S. MFN drug pricing policy has become a major issue at events held by pharmaceutical companies seeking to launch their products in Korea and receive reimbursement. Interest is focused on why some companies are attempting reimbursement despite the uncertain situation. Junil Kim, General Manager of Astellas Korea, explained, “It is true that companies selling their products in the U.S. market are facing difficulties in receiving Korean drug prices due to MFN-related issues. Astellas, which accounts for nearly 50% of its sales in the U.S., is no exception.” In the clinical field as well, there is a growing consensus that concerns surrounding the introduction of new drugs due to global pharmaceutical companies' MFN pricing policies are valid. This is expected to spark debate over the “Korea passing” issue for new drugs in the future. If the situation intensifies, there are concerns that it could lead to delays in access to innovative new drugs, reduced treatment options for patients, and increased financial burdens on patients in Korea. In the long term, this is also expected to jeopardize the competitiveness of conducting clinical trials in Korea in the global market. The Korean Society of Gastroenterology pointed out in its own medical policy forum that “there is a possibility that excessively low drug pricing policies could trigger the ‘Korea passing’ phenomenon, leading to the withdrawal of global pharmaceutical companies from the Korean market.” "Despite receiving approval in Korea as a treatment for ulcerative colitis, Eli Lilly's Omvoh was not released in Korea due to an unreasonably low drug price proposed during price negotiations. A policy is needed that ensures patient access to treatment while maintaining the sustainability of the health insurance budget. Rather than pursuing excessive drug price cuts that could lead to market withdrawal, a strategic approach that promotes the introduction of new drugs from a long-term perspective should be devised.”
- Company
- Expanded competitiveness of K-Bio immunotherapies
- by Son, Hyung Min Aug 26, 2025 06:05am
- Korean pharmaceutical and biotech companies are entering the development of immunotherapies, increasing the possibility of 'big deals' with global pharmaceutical companies. As competition for new drugs targeting next-generation immune checkpoint proteins intensifies, Aprogen has begun developing VISTA targets by securing an antibody candidate from PharmAbcine. Companies such as Yuhan Corp, Hanmi Pharmaceutical, ImmuneOncia, and STCube are also implementing differentiated strategies with new target-based immunotherapies. Aprogen Secures PharmAbcine's Immunotherapy Candidate… 'Free supply agreement for Keytruda' According to the Financial Supervisory Service's electronic disclosure system on August 23, Aprogen recently secured an exclusive license for the research, development, and commercialization of the immunotherapy candidate PMC-309 through an agreement with PharmAbcine. Aprogen also obtained the rights for its manufacturing and production. The total contract value exceeds 10% of PharmAbcine's consolidated equity capital of KRW 47.7 billion as of last year, and the specific terms are undisclosed. The contract period runs from August 18, 2025, until the expiration of the final valid claim of the licensed patent. PMC-309 works by enhancing T-cell activity by blocking VISTA on the surface of immune T-cells and reducing the immunosuppressive function of myeloid-derived suppressor cells (MDSCs) to normalize the tumor microenvironment. This new drug candidate was discovered through PharmAbcine's fully human antibody library, 'HuPhage,' and specifically targets VISTA, a next-generation target for immunotherapy. A Phase 1 clinical trial of PMC-309 is currently underway in Australia. The Phase 1a part of the trial evaluates safety and pharmacokinetics with monotherapy, starting from low to high doses. The Phase 1b part will verify its combination effect with MSD's 'Keytruda.' MSD signed a free supply agreement for Keytruda with PharmAbcine in 2021, and this arrangement remains in effect for the current trial. The trial's patient enrollment goal is 67, with the first dose administered in November 2023. The expected completion date is 2028. Aprogen expects to see tumor shrinkage signals as early as the low-dose stage and anticipates a more pronounced anti-cancer effect at intermediate doses. Aprogen plans to quickly initiate the Keytruda combination Phase 1b trial once the target signals are confirmed at the intermediate dose, and to pursue early out-licensing to MSD if superior efficacy is proven in the combination therapy. Major Entry into Immunotherapy Market…All-Out Effort for Technology Transfer New antibody-drug conjugates (ADC)The immunotherapy development strategy of Korean companies can be summarized as 'signals,' 'speed,' and 'deal-making.' The structure involves securing meaningful response rates and safety data in the early clinical stage and using this as a basis to complete early technology transfers with global partners. This is why Korean companies are pursuing combinations with already commercialized immunotherapies or antibody-drug conjugates (ADCs). This Aprogen-PharmAbcine technology transfer deal is also notable for its collaboration with MSD, which opens the door for early technology transfer to a global pharmaceutical company. The industry is paying close attention to whether a major deal can be made when the clinical response rate, duration of response, and toxicity profile are disclosed. Currently, not only Aprogen and PharmAbcine but also Yuhan Corp, Hanmi Pharmaceutical, STCube, and GI Innovation are developing next-generation immunotherapies. Yuhan Corp recently received approval from the Ministry of Food and Drug Safety for its Phase 1/2 clinical trial plan (IND) for the bispecific antibody immunotherapy candidate 'YH32364.' YH32364 is a new drug candidate that Yuhan Corp in-licensed from ABL Bio in 2018. This trial is the first human dose study for YH32364. Yuhan Corp will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of YH32364 in patients with locally advanced or metastatic solid tumors that have confirmed overexpression of the epidermal growth factor receptor (EGFR). YH32364 is a bispecific antibody immunotherapy candidate that simultaneously targets EGFR and 4-1BB. Yuhan Corp plans to maximize the anti-tumor effect by simultaneously targeting EGFR, a biomarker expressed in major solid tumors like non-small cell lung cancer and colorectal cancer, and 4-1BB, which is involved in T-cell activation. Hanmi Pharmaceutical is conducting a Phase 1 clinical trial for its bispecific antibody immunotherapy candidate, 'BH3120.' BH3120 simultaneously targets PD-L1 and 4-1BB. As PD-L1 is a target where immunotherapies like Keytruda and Opdivo have proven their efficacy, Hanmi Pharmaceutical plans to enhance this effect by adding a 4-1BB protein target. GI Innovation recently changed its U.S. Phase 1/2 clinical trial for the immunotherapy candidate 'GI-102' to a study evaluating its combination therapy with Enhertu. GI-102 is a pipeline that targets CD80 and Interleukin (IL-2) to target tumor and immune cells. It has been engineered to have an even lower binding affinity to the alpha receptor compared to GI-101A. It is known that a high binding affinity to the alpha receptor increases regulatory T-cells, which reduces the anti-cancer effect. GI-102 is also being developed in a subcutaneous (SC) formulation, in addition to the intravenous (IV)formulation. The potential of GI-102 was also confirmed in a monotherapy trial. According to Phase 1/2a data recently disclosed by the company, GI-102 showed an objective response rate (ORR) of 43% in patients with melanoma. When GI-102 was administered, lymphocyte proliferation proceeded smoothly, and no serious drug toxicity was observed in terms of safety. GI Innovation anticipates a more pronounced effect when GI-102 is used in conjunction with Enhertu. The company believes that combining GI-102 with a reduced dose of Enhertu may decrease side effects, such as interstitial lung disease (ILD), which can occur with Enhertu. STCube is set to disclose the clinical results of 'Nelmastobart,' which targets the new biomarker BTN1A1. BTN1A1 is a protein that regulates the immune response to cancer cells by suppressing the activity of immune cells, T-cells. This biomarker is not expressed in normal cells but is strongly expressed in cancer cells, and its expression is mutually exclusive with PD-L1. ST Cube is developing an immunotherapy that targets BTN1A1, which could be a new treatment option for intractable cancers. ST Cube is currently conducting a U.S. and Korean Phase 1b/2 trial of Nelmastobart in combination with paclitaxel for patients with relapsed, refractory, and extensive-stage small cell lung cancer (ES-SCLC). The company is also investigating the potential of a Nelmastobart and capecitabine combination therapy as a third-line or later treatment for metastatic colorectal cancer. TiumBio recently disclosed the Phase 2 clinical trial results for its immunotherapy candidate 'TU2218' in combination with MSD's immunotherapy 'Keytruda.' TU2218 simultaneously blocks the pathways of transforming growth factor-beta (TGF-ß) and VEGF, which are known to inhibit immunotherapy activity, thereby maximizing the efficacy of immunotherapies. The disclosed trial represents the early cohort results from an ongoing study in patients with head and neck cancer and biliary tract cancer. The clinical results showed that the TU2218 + Keytruda combination therapy resulted in a partial response (PR) in 7 out of 11 patients with head and neck cancer, with stable disease (SD) observed in 1 patient. In the biliary tract cancer cohort, 4 out of 23 patients showed PR, and 7 showed SD. ImmuneOncia is conducting clinical trials for its immunotherapy candidate 'IMC-002.' IMC-002 has a mechanism that blocks signals between CD47 on cancer cells and macrophages. The recently disclosed results are the initial findings from an ongoing Phase 1b clinical trial in patients with hepatocellular carcinoma. The trial is evaluating the tolerability and safety of IMC-002 in combination with Lenvima, which is used to treat hepatocellular carcinoma. Among 10 patients who could be assessed for efficacy, the ORR was 30%, and the disease control rate (DCR) was 70%. The median time to progression (TTP) was 8.3 months.
- Company
- Jaypirca may be prescribed at general hospitals in Korea
- by Eo, Yun-Ho Aug 26, 2025 06:04am
- The BTK inhibitor Jaypirca may now be prescribed in general hospitals in Korea. According to industry sources on the 22nd, Lilly Korea’s relapsed and refractory mantle cell lymphoma treatment Jaypirca (pirtobrutinib) has passed review of Drug Committees (DCs) at medical institutions in Korea, including Samsung Medical Center, Pusan University Yangsan Hospital, and Ulsan University Hospital. As the company is currently in the final stages of price negotiations for Jaypirca with the National Health Insurance Service, it is expected that if it successfully secures insurance reimbursement, it will be immediately prescribed on-site. The drug was approved last August by the Ministry of Food and Drug Safety as a monotherapy in adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received two or more treatments, including BTK inhibitors. Prior to its approval, there were no approved medications available for patients with relapsed or refractory MCL whose disease progressed after treatment with existing BTK inhibitors in Korea. Also, Jaypirca is the first and only reversible BTK inhibitor that has demonstrated clinical efficacy in patients with relapsed or refractory MCL following treatment with one or more BTK inhibitors. It also exhibits a 300-fold higher selectivity for BTK compared to most kinases (98%) included in preclinical studies. The study that became the basis of Jaypirca’s approval was the BRUIN Phase I/II clinical trial, which evaluated the clinical efficacy and safety of Jaypirca in adult patients with relapsed or refractory mantle cell lymphoma who had previously received treatment with one or more BTK inhibitors. In the primary analysis set (PAS) of 90 patients who had previously received one or more BTK inhibitors, the overall response rate (ORR) was 56.7%, with a median duration of response (DoR) of 17.6 months. The most common adverse reactions following Jaypirca administration were fatigue (26.3%), neutropenia (22.8%), diarrhea (22.1%), and bruising (19.0%). The incidence of treatment discontinuation due to adverse reactions was 1.2%, and the incidence of dose reduction due to adverse reactions was 3.3%. Meanwhile, based on the response rate results, Jaypirca was approved through the U.S. FDA's accelerated approval process in January last year. In Korea, it was designated as an orphan drug in June last year for use as monotherapy in adult patients with relapsed or refractory MCL who had previously received treatment with a BTK inhibitor.
- Policy
- SK chemicals' Afstyla will be removed from the reimb list
- by Lee, Tak-Sun Aug 25, 2025 06:08am
- Product photo of Afstyla SK chemicals' hemophilia A treatment, Afstyla, which was out-licensed by the company, will be removed from the reimbursement list due to a lack of record of supply performance. The product's delisting was previously deferred in 2023 through conditional negotiation, but with no sales to show since, the decision to remove it has become final. This is a regrettable outcome for a product developed by a domestic company and out-licensed globally. According to industry sources, Afstyla will be removed from the reimbursement list, effective September 1. The product received a decision for removal in 2023 after a review of non-billed drugs revealed no sales over the previous three years; however, its delisting was put on hold through conditional negotiation. However, with no sales recorded within the negotiation period, the decision to remove it has been finalized. Afstyla is currently on the reimbursement list with a price cap of KRW 625 per dose. Afstyla is a biosimilar developed by SK chemicals and out-licensed to CSL Behring Australia during the clinical trial phase in 2009. CSL Behring completed the trials and received approval for the drug in the U.S. and Europe. In 2020, it obtained domestic approval and was added to the reimbursement list in 2021. SK Plasma, an affiliate of SK chemicals, was responsible for domestic sales. In 2020, it obtained domestic approval in Korea and was added to the reimbursement list in 2021. SK Plasma, an affiliate of SK chemicals, was responsible for domestic sales. However, entering the hemophilia market in Korea proved difficult due to the strong presence of established pharmaceutical companies, such as Green Cross, which has a solid position with the hemophilia market. It is also believed that the market outlook was not bright due to the successive launch of competing new drugs. In a 2023 review of non-billed drugs, the product had no production track record for the past three years. However, the manufacturer was able to delay delisting by explaining that sales would soon occur or production would be completed. But after two years with no sales, Afstyla will be removed from the reimbursement list. CSL Behring launched Idelvion, a hemophilia B treatment with improved patient convenience, in Korea last year. With the delisting of Afstyla, it appears CSL Behring will shift its focus to supplying Idelvion.
- Company
- 'New treatment opportunities rise for acquired hemophilia A'
- by Whang, byung-woo Aug 25, 2025 06:06am
- There is an extremely rare bleeding disorder that affects one in every 100,000 people. It is acquired hemophilia A, a condition in which healthy individuals experience unexplained bruising and severe bleeding throughout the body. Until recently, there were limited treatment options available for emergencies, causing significant challenges for medical staff in controlling the patients’ bleeding. Episodes. In this context, the introduction of “Obizur ( susoctocog alfa), a blood coagulation factor VIII agent” as the first treatment for adult acquired hemophilia A in Korea last year, followed by its reimbursement, has brought about major changes in the treatment environment. Dailpharm met with Jin Seok Kim, Professor of Hematology at Severance Hospital, to discuss the changes brought about by the introduction of Obizur in clinical practice and the challenges that remain. Unexplained autoimmune bleeding…delayed diagnosis can be fatal Jin Seok Kim, Professor of Hematology at Severance Hospital While congenital hemophilia is a bleeding disorder caused by genetic factors, acquired hemophilia A occurs when antibodies against blood coagulation factor VIII (Factor VIII) are produced due to an autoimmune response. This rare disease causes bleeding by inhibiting the function of Factor VIII, and its symptoms appear similar to those of congenital hemophilia, such as bruising or bleeding. Professor Kim explained, “While acquired hemophilia can arise secondary to malignant tumors, autoimmune diseases, medications, or pregnancy, approximately 50% of cases are reported as idiopathic, meaning they occur without a clear underlying cause. Given its rarity and unfamiliarity, patients may feel overwhelmed, but some cases can progress to severe bleeding requiring emergency treatment, making prompt diagnosis critically important.” According to statistics from Western countries, the incidence is approximately 1 in 1 million people, which translates to about 50 cases per year in South Korea based on its population. However, the actual number of reported cases in the country is much lower, estimated at around 20 per year. Professor Kim added, “Since acquired hemophilia A is such a rare disease, general medical staff are often unaware of it, leading to delayed diagnosis. When treating patients with unexplained generalized bleeding or atypical bleeding patterns, it is crucial to actively work with a hematologist.” The primary goal of treatment for acquired hemophilia A is to stop life-threatening bleeding while removing antibodies to prevent recurrence quickly. This requires concurrent hemostatic therapy and immunosuppressive therapy, a process that is highly complex and challenging. Professor Kim explained, “Acquired hemophilia A requires not only hemostasis but also immunosuppressive therapy to remove autoantibodies, which can make treatment complex and risky. Highly potent immunosuppressants such as steroids and cyclophosphamide must be used to remove antibodies, but in elderly patients, the risk of severe infections such as pneumonia and sepsis is high, and death from infection during treatment is not uncommon.” Intoduction of Obizur changes the paradigm of acquired hemophilia A treatment There were also difficulties in selecting emergency hemostatic agents. Prior to the introduction of Obizur, bypassing agents were the standard hemostatic treatment for acquired hemophilia A. These are medications that bypass the deficient Factor VIII in the body and help form fibrin clots through an alternative pathway. In South Korea, recombinant activated Factor VII (rFVIIa, eptacog alfa) was primarily used as first-line therapy. rFVIIa activates blood clotting factors in a short time to induce temporary hemostasis, but it has the limitation of a very short duration of action (half-life) of approximately 2 hours. Professor Kim mentioned, “Due to its very short half-life of two hours, as well as the high cost of the drug and reimbursement limitations, it was difficult to adhere to the recommended dosing interval (two hours), resulting in insufficient hemostasis or recurrent bleeding in many cases.” In this situation, Obizur, which was reimbursed last year, is said to have brought a positive impact. Obizur is a recombinant porcine sequence factor VIII (rpFVIII) drug developed to avoid cross-reactivity with human factor VIII autoantibodies. It can replace factor VIII to achieve hemostatic effects and has a longer half-life of approximately 10 hours, enabling stable and sustained hemostatic management. Professor Kim stated, “It has been just over a year since Obizur was introduced. While we are still accumulating clinical evidence, experts on the front lines are clearly sensing positive changes. Obizur is evaluated as having equivalent hemostatic efficacy and effectiveness to existing bypass therapies, but with the ability to monitor treatment responses more objectively, which is a key differentiator.” When using existing bypass therapies, decisions on dose reduction or treatment termination were based solely on the patient's clinical bleeding signs. However, Obizur allows for objective determination of treatment dose and duration by measuring plasma factor VIII levels. He explained, "Once bleeding is controlled, treatment can be discontinued early based on numerical confirmation, and conversely, additional doses can be administered if levels do not rise sufficiently, enabling personalized treatment. This reduces unnecessary overdose and the risk of side effects such as thrombosis, and since only the optimal dose for each patient is used, the cost of treatment is also reduced.” Reimbursement standards still remain a barrier... “Clinical judgment should be taken into account in reimbursement decisions” Although the treatment environment for acquired hemophilia A has improved significantly with the introduction of Obizur, practical constraints and remaining challenges still do exist. One of the most notable issues is its health insurance reimbursement criteria. Currently, under Korea’s reimbursement standards, only patients with antibody titers of 5 BU or higher are eligible for reimbursement for bypass agents or Obizur, which is the same as for congenital hemophilia patients. However, experts believe that the current criteria, which require selecting medications based on antibody titers, are inappropriate for acquired hemophilia as there is a low correlation between antibody titers and bleeding severity. Professor Kim stated, “Under the current reimbursement criteria, it is necessary to confirm the antibody titer before starting treatment and determine insurance coverage, which can lead to treatment delays or administrative burdens. Additionally, the 5BU standard is not applied in any domestic or international treatment guidelines.” He further explained, “Even with low antibody titers, severe bleeding can occur in acquired hemophilia, so clinical manifestations may differ significantly even if test results are similar. Therefore, it is necessary to improve the system to determine insurance coverage based on the patient's bleeding patterns and clinical judgment rather than quantitative criteria.” In addition, Professor Kim emphasized the need to prompt early diagnosis by raising disease awareness. He explained, “Even if effective treatments exist, delayed diagnosis inevitably worsens prognosis, and ultimately, the success of treatment depends on how fast we diagnose the condition. Since acquired hemophilia is a rare disease, the general medical staff have low awareness, leading to delayed initial diagnosis. Improving disease awareness is essential to prevent deaths caused by severe bleeding in the early stages.”
- Policy
- NHIU ‘Eradicate rebates with INN-based prescriptions'
- by Lee, Tak-Sun Aug 25, 2025 06:06am
- The National Health Insurance Trade Union stressed the need to eradicate pharmaceutical rebates by improving the drug pricing system and distribution structure to those of advanced country standards. The union also advocated the introduction of generic substitution through international nonproprietary name prescriptions. On the 18th, it was revealed through a prosecution investigation that a pharmaceutical wholesaler had provided approximately KRW 50 billion in illegal rebates to three general hospitals through a new scheme involving the establishment of a shell company to pay dividends. The NHIU stated, “The inflated drug costs resulting from illegal rebates and bid-rigging are being passed on to the public in the form of higher medical expenses, leading to unnecessary overprescription of medications and causing serious harm to the health and lives of citizens. This serves as a major factor contributing to the leakage of Koera’s health insurance finances, ultimately resulting in increased health insurance premiums for both citizens and businesses.” The provision of rebates by medical professionals is strictly prohibited under the current Medical Services Act (Article 23-5) and the Pharmaceutical Affairs Act (Article 47). Despite this, in July, the Korea National Police Agency's National Investigation Headquarters announced that it had identified 597 individuals in the medical and pharmaceutical fields suspected of illegal rebates through a special crackdown on illegal rebates and public official corruption. This investigation result demonstrated that illegal rebates in the medical field remain widespread despite the introduction of the dual punishment system for rebates 15 years ago. According to the NHIU, recent illegal rebates in the medical field have been cleverly evading enforcement by exploiting investigative blind spots caused by limited manpower in law enforcement agencies such as the police and prosecution, through more indirect and sophisticated methods such as academic support and consulting. In some cases, an “indirect supplier” is involved as an additional distribution channel between wholesalers and medical institutions, and to circumvent the principle of “one person, one facility” under the Medical Services Act (prohibiting duplicate establishments), wholsalers have been registering indirect suppliers under the names of family members or others related to the medical professionals, leveraging their monopolistic position to extort unfairly low prices from pharmaceutical suppliers and provide illegal rebates to medical professionals. Recently, the Organization for Economic Cooperation and Development (OECD) reported in its ‘Health Statistics 2025’ that South Korea's pharmaceutical expenses are 47% higher than the average of OECD member countries. The NHIU stated, “Enforcement and punishment alone are insufficient to break the vicious cycle of illegal pharmaceutical rebates that recur every year. Fundamental solutions include improving drug pricing systems and distribution structures through price competition among suppliers, such as government tenders and individual drug price negotiations, or introducing flexible pricing systems like reference pricing. Also, the activation of generic substitution based on product names or ingredient names, which is implemented or recommended practice in most advanced countries with separation of prescribing and dispensing systems, is necessary.” They cited Spain as an example. Spain, which has a similar population to South Korea, saves EUR 200 million annually (as of 2017, with a generic substitution rate of 53%) through generic substitution using the International Nonproprietary Name (INN). The union stated that introducing generic substitution through INN-based prescriptions in South Korea could result in annual savings of at least KRW 500 billion in health insurance funds. The NHIU declared, “To eliminate pharmaceutical rebates that threaten the health insurance budget, we will form a united front with labor and civil society organizations that share our vision and set up a proactive and systematic management strategy to improve the drug pricing system and pharmaceutical distribution structure.” It added, “The government and National Assembly must actively pursue legal and institutional reforms to eradicate illegal pharmaceutical rebates. This is because the ‘black money’ from illegal pharmaceutical rebates should no longer be passed on to the public, who already pay the world's highest pharmaceutical costs.” The statement emphasized that pharmaceutical rebates, which exacerbate the public's medical expenses and hinder the sustainable development of the health insurance system, must be eradicated through reforms to establish a drug pricing system and distribution structure on par with those of advanced countries.
- Policy
- IV formulation of Korea’s first IL-23 drug Tremfya approved
- by Lee, Hye-Kyung Aug 25, 2025 06:05am
- The intravenous injection formulation of Tremfya, the first interleukin-23 (IL-23) inhibitor in Korea, was recently granted approval, paving the way for the supply of all Tremfya injection formulations in Korea. On the 21st, the Ministry of Food and Drug Safety approved Janssen Korea's Tremfya Intravenous Injection (guselkumab, recombinant DNA). In addition to receiving approval for ‘Tremfya Prefilled Syringe’ in 2018 and ‘Tremfya OnePress Autoinjector’ in 2021, the company has now received approval for the intravenous injection formulation and may now introduce the formulation to Korea. The indications for Tremfya vary depending on the formulation. The pre-filled syringe formulation is indicated for plaque psoriasis, palmoplantar pustulosis, psoriatic arthritis, ulcerative colitis, and Crohn's disease. The intravenous injection recently approved is used for the induction therapy of ulcerative colitis and Crohn's disease. The 200mg intravenous injection is administered intravenously over a minimum of 1 hour on weeks 0, 4, and 8, followed by maintenance therapy using Tremfya Prefilled Syringe Injection or Tremfya OnePress Autoinjector. Therefore, the intravenous injection is indicated only for the treatment of moderate-to-severe active ulcerative colitis or Crohn's disease in adults who have not responded adequately, have lost response, or have intolerance to conventional therapies, including biological agents or small-molecule drugs. Meanwhile, Tremfya is the first and only interleukin-23 inhibitor approved in Korea for psoriatic arthritis, and its reimbursement criteria are being continuously expanded. Psoriatic arthritis is a chronic progressive immune disease characterized by joint inflammation, enthesitis (inflammation at the sites where bones, tendons, and ligaments meet), dactylitis (severe inflammation of the fingers and toes), and pain in the hands and feet, commonly occurring in individuals aged 30–50 years. To date, there is no cure for psoriatic arthritis, and despite available treatment options, many patients experience symptoms that impair their ability to perform daily activities. It is estimated that approximately 9% of psoriasis patients in South Korea develop psoriatic arthritis.
- Company
- Lilly seeks Mounjaro’s reimbursement for diabetes in Korea
- by Eo, Yun-Ho Aug 22, 2025 06:08am
- ‘Mounjaro,’ which is causing a roar in the field of obesity treatment, is seeking inclusion in insurance reimbursement for its diabetes indication. According to Dailpharm coverage, Eli Lilly Korea has submitted a reimbursement application for its Mounjaro (tirzepatide), a dual GIP/GLP-1 receptor agonist, and is proceeding with the necessary procedures to present the application for review to the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service. Therefore, it remains to be seen whether Mounjaro, a drug for obesity and diabetes, will be listed for reimbursement in Korea. Mounjaro is a single-molecule designed to selectively bind to and activate the GIP receptor and GLP-1 receptor with a once-weekly injection. It helps lower blood sugar by promoting insulin secretion, improving insulin sensitivity, reducing glucagon levels, delaying stomach emptying, and reducing food intake, thereby aiding weight loss. Although its obesity indication is well-known, Mounjaro has achieved significant results in the field of diabetes as well. Beyond just achieving the blood sugar control targets, 6 out of 10 patients achieved normal blood sugar levels without an increased risk of hypoglycemia, reaching the ultimate treatment goals of preventing cardiovascular complications and reducing mortality. It has even demonstrated the potential for “remission” in diabetes. In diabetes, Mounjaro is approved as an adjunct to diet and exercise therapy for improving glycemic control in adults with type 2 diabetes (as monotherapy or as part of a two-drug regimen). The approval of its type 2 diabetes indication approval was based on a randomized, double-blind, placebo-controlled study comparing Mounjaro (5 mg, 10 mg, or 20 mg) with placebo, semaglutide (1 mg), insulin degludec (100 U/mL), and insulin glargine (100 U/mL) in five SURPASS Phase III clinical trials (total of 6,278 participants). Mounjaro significantly improved HbA1c compared to the control group and baseline in all studies. Meanwhile, the top-line results from the Phase III SURPASS-CVOT study, which demonstrated the cardiovascular benefits of Mounjaro, have recently been disclosed. In the study, Mounjaro demonstrated non-inferiority compared to Trulicity in the incidence of 3-point major cardiovascular events (MACE-3), including cardiovascular disease death, myocardial infarction, and stroke, thereby achieving the primary endpoint of the clinical trial. Additionally, it showed improvements in key outcomes, including HbA1c, weight, kidney function, and all-cause mortality.
- Policy
- Blockbuster drugs, Atozet·Rosuzet, get price cuts
- by Lee, Tak-Sun Aug 22, 2025 06:07am
- It has been reported that prices for blockbuster drugs, including the hyperlipidemia combination therapies Atozet (Organon) and Rosuzet (Hanmi Pharmaceutical), are expected to be reduced due to increased usage. These hyperlipidemia combination therapies are frequently subject to annual volume-based drug price negotiations (PVA). Additionally, Celltrion's antibody biosimilar Remsima and Dong-A ST's growth hormone product Growtropin-II Inj are also reported to be on the list for price cuts. On August 21, industry sources reported that reimbursement caps for several products would be adjusted as of September 1, under the 'Type-Da' Price-Volume Agreement. The number of blockbuster products is reported to be included this time. The reimbursement cap for Organon's hyperlipidemia combination therapy, Atozet Tab (atorvastatin-ezetimibe), is expected to be reduced by 3.4% following negotiations. The prices of the 10/10mg, 10/20 mg, 10/40 mg, and 10/80 mg products will be adjusted as follows: 10/10 mg from KRW 951 to KRW 918, 10/20mg from KRW 1,209 to KRW 1,168, 10/40mg from KRW 1,299 to KRW 1,255, and 10/80mg from KRW 1,387 to KRW 1,340. Atozet's outpatient prescription sales last year, based on UBIST data, were KRW 118.7 billion, a 16.3% increase from KRW 102.1 billion in the previous year. The increase in prescription sales alone exceeded KRW 16 billion. This year's negotiation targets for Type-Da Price-Volume Agreement include products whose 2024 claim amount increased by more than 60% compared to 2023, or products that increased by more than 10% with the increase exceeding KRW 5 billion. Based on UBIST data, Atozet meets these criteria. Hanmi Pharmaceutical's hyperlipidemia combination therapy, Rosuzet Tab (rosuvastatin-ezetimibe), is also reported to have undergone a price cut. Rosuzet Tab's reimbursement cap is expected to be reduced by 1.3% to 2.1% depending on the dosage. The prices for the 10/10mg dose are expected to be reduced from KRW 1,103 to KRW 1,087, the 10/20mg dose from KRW 1,111 to KRW 1,093, the 10/5mg dose from KRW 789 to KRW 779, and the 10/2.5mg dose from KRW 727 to KRW 712. Rosuzet recorded outpatient prescription sales of KRW 210.2 billion last year, a 17.6% increase from KRW 178.8 billion in the previous year. HK inno.N's Rovazet and Yuhan Corp.'s Rosuvamibe, which contain the same ingredients as Rosuzet, will also have their reimbursement caps lowered in this negotiation. Rovazet recorded outpatient prescription sales of KRW 47.4 billion last year (up 23%), and Rosuvamibe recorded KRW 89.1 billion (up 14.6%) based on UBIST data. Celltrion's antibody biosimilar , Remsima, used for the treatment of rheumatoid arthritis and other conditions, will also have its price adjusted due to increased usage. Remsima is a biosimilar of Remicade, a blockbuster product with global sales of over KRW 1 trillion. Its reimbursement cap is scheduled to be lowered by 1.2% through an agreement with the NHIS. Dong-A ST's growth hormone product, Growtropin-II Inj, is also on the rise.Growtropin-II Inj's reimbursement cap was adjusted last year due to the Price-Volume Agreement as well. Additionally, Janssen's ADHD treatment Concerta OROS ER Tab is expected to see a 3.9% reduction in its reimbursement cap. Meanwhile, this year's Price-Volume Agreement price reduction list reportedly does not include any of the choline alfoscerate products for cognitive enhancement. These products, which included six items last year, had been consistently on the PVA list. However, after the decision was made to apply selective reimbursement to choline alfoscerate products in a reimbursement re-evaluation, pharmaceutical companies shifted their business to alternative products, which seems to have halted their growth.
- Policy
- ALS drug Qalsody is approved in Korea with a condition
- by Lee, Hye-Kyung Aug 22, 2025 06:07am
- The ALS treatment ‘Qalsody (tofersen)’ has been approved under the condition that the results of its therapeutic confirmatory clinical trial be submitted later. According to the advisory council’s review results regarding the safety and efficacy of Qalsody, which was released by the Ministry of Food and Drug Safety on the 20th, the council saw consensus on the need to grant conditional approval for Qalsody, given how ALS worsens over time and treatment options are limited. Biogen's Qalsody is a nucleic acid therapy that binds to SOD1 mRNA in patients with ALS caused by mutations in the superoxide dismutase 1 (SOD1) gene, reducing the synthesis of mutated proteins (SOD1). It received domestic approval from the MFDS on the 20th of this month. According to the CPAC meeting results, experts noted that ALS is a highly severe disease that can be fatal without treatment, and that there are no specific medications available for the condition at the present. In particular, Qalsody’s indication is limited to ALS patients with SOD1 gene mutations. While the mechanism of action involves binding to mRNA, entering the nucleus, and inhibiting SOD1 expression, there were opinions that it is difficult to directly evaluate or reflect the actual SOD1 secreted externally. A member of the CPAC stated, “Based on the submitted data, the drug seems to show an effect when NfL correction is applied. In neurodegenerative diseases, biomarkers can sufficiently explain the extent of neural damage, and as there is scientific evidence on their effect, conditional approval was deemed appropriate.” Another member explained, “This disease is a rare and severe condition with no available treatments in the country, and existing approved drugs are primarily used for symptom relief. Given the clinical trial results based on the NfL biomarker and its potential to control the disease, we deemed that the benefits are significant and agree to grant a conditional approval.” However, there was also an opinion that the completion date of the conditional Phase III clinical trial should be considered, as patients with SOD1 mutations account for less than 3% of all ALS patients, which may require a longer patient recruitment period. Experts also suggested that conditional approval is necessary to provide treatment opportunities for domestic patients, as the drug is already in use overseas. In other words, the council saw that the safety and efficacy of the drug are deemed acceptable based on the data submitted by the pharmaceutical company, and conditional approval is needed to allow patients to benefit from the treatment as soon as possible. Meanwhile, Qalsody was approved in Korea through the accelerated approval process, the Global Innovative products Fast-Track (GIFT), as the 31st product.
