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- 2026-04-03 18:32:39
- Policy
- Faslodex’s price stays as is…supply instability concerns
- by Lee, Tak-Sun Aug 05, 2025 06:08am
- The breast cancer drug Faslodex (fulvestrant, AZ Korea), was facing a price cut due to the expiry of its premium pricing period, but this was prevented by the pharmaceutical company's request for a stay of execution. On the 31st of last month, the MOHW announced that the court had temporarily suspended the execution of the disposition to reduce the insurance price ceiling for Faslodex until August 31. The expiration of the premium pricing period for Faslodex was scheduled following the entry of generic drugs. Although the one-year price adjustment period expired in 2023, it was extended for an additional 2 years because three or fewer companies were producing the same drug. The price of AstraZeneca's Faslodex Inj was scheduled to be reduced from KRW 376,724 to KRW 288,194, while Boryung’s Fulvet Inj’s price was set to decrease from KRW 357,888 to KRW 288,194 as a Korean innovative pharmaceutical company’s product. At the time, AstraZeneca and Boryung requested an extension of the premium pricing period, citing supply issues prior to its expiration. However, with the emergence of Hankook Korus Pharm’s “Elbracan inj,” a domestically produced generic version of the drug, the insurance authorities decided in February to end the premium pricing as planned. Boryung Fulvet's price was reduced as planned, while AZ Faslodex's price remained unchanged due to the suspension of the administrative disposition. The Faslodex issue unexpectedly came up during Minister of Health and Welfare Eun-kyung Jeong’s confirmation hearing last month. In a written Q&A, the then-candidate exchanged with the NA before the confirmation hearing, multiple members of the National Assembly raised concerns about potential supply disruptions due to the termination of the premium pricing. At the time, Jeong, “Two identical drugs (substitutes) from other companies are currently listed, so the Drug Reimbursement Evaluation Committee (DREC) decided to terminate the preimium pricing for Faslodex,” adding, “We will manage generic drug prices at an appropriate level and strengthen domestic production and supply bases to ensure a stable supply of essential drugs.” The original manufacturer and patient groups argue that Faslodex, which was designated as a national essential medicine in November last year, requires price protection measures. The multinational pharmaceutical company AZ is reportedly considering withdrawing from the Korean market if Faslodex’s prices are reduced due to the end of the premium pricing period. However, domestic insurance authorities maintain that they decided to end the price adjustment period in accordance with principles, as domestic generic drugs are now available and there are no supply issues with the generic versions. AZ appears to have planned to continue domestic supply while maintaining its drug’s price through the lawsuit. However, if the court ultimately rejects the request for a stay of execution or if AZ loses the lawsuit, there is a possibility that the company’s global headquarters could decide to withdraw the drug from the domestic market. If the supply of the original anticancer drug is discontinued, its impact on the market could be significant, even if generic drugs are available. Given the nature of anticancer drugs, there is a strong preference for the original product, and with the original drug already holding a 90% market share, it would be difficult to immediately switch to generics. Accordingly, while the insurance authorities have upheld the principle of ending the premium pricing for Faslodex, the analysis is that special management would be necessary to prevent future supply issues. An industry insider explained, “Compared to AstraZeneca's withdrawal of the diabetes treatment drug Forxiga from the domestic market last year, the situation with Faslodex is not as straightforward. While Forxiga is a chronic disease treatment that can be replaced by generics, Faslodex is a life-saving drug for cancer patients, and cannot be immediately substituted with its generic versions.”
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- Inclusion of Prevenar 20 into NIP for children starting Oct
- by Whang, byung-woo Aug 05, 2025 06:08am
- As Prevenar 20 has been confirmed to be included in the National Immunization Program (NIP) in October, a fierce market competition is anticipated. Product photo of Prevenar 20 PFSThe implementation has been delayed from its initial expected schedule in Q3. However, it is anticipated to shift the market for pneumococcal conjugate vaccines with the emergence of the newest version of the vaccine, following 13-valent and 15-valent vaccines. The Korea Disease Control and Prevention Agency announced on the 4th that Prevenar 20, which is the newest pneumococcal conjugate vaccine, will be officially introduced as part of the NIP. Accordingly, children over two months of age and adolescents can receive free vaccinations with Prevenar 20 at medical clinics nationwide. Prevenar 20 is a pneumococcal conjugate vaccine that was approved by the Ministry of Food and Drug Safety (MFDS) on October 31, 2024. Compared to the 13-valent vaccine, Prevenar 20 has added seven additional pneumococcal serotypes. Among domestically approved pneumococcal conjugate vaccines, it contains the most serotypes. As Prevenar 20 includes common serotypes in Korea that could not be prevented using existing vaccines, its preventative effect is garnering attention. Pneumococcus is a major bacterial pathogen that causes various diseases in infants and young children, including otitis media, pneumonia, and meningitis. Vaccination is crucial, especially as it can cause life-threatening invasive pneumococcal disease (IPD) in immunocompromised children. The inclusion of Prevenar 20 in the NIP was decided after a comprehensive review by the Korea Expert Committee on Immunization Practices (KECIP) on the vaccine's safety, immunogenicity, and cost-effectiveness. With this introduction, the number of pneumococcal vaccines supported by the NIP will increase to three. Types of Pneumococcal Conjugate Vaccines (PCVs) per Serotypes Currently, the NIP supports the 13-valent pneumococcal conjugate vaccine (PCV13, Prevenar 13) and the 15-valent pneumococcal conjugate vaccine (PCV15, Vaxneuvance) for pediatric pneumococcal vaccination. The vaccination schedule for Prevenar 20 in healthy children remains the same: a total of three doses at 2, 4, and 6 months of age, followed by a booster dose at 12-15 months. Children who have already started vaccination with PCV13 can receive an interchangeable vaccination with PCV20. For this reason, it is expected that many infants who have completed their first or second doses with PCV13 will continue the remaining schedule with PCV20. Experts also anticipate a higher incidence of interchangeable vaccination with the newer vaccine, which offers broader protection compared to existing vaccines. However, the KDCA recommends that if vaccination begins with PCV15, the remaining doses should be completed with the same vaccine. Additionally, PCV20 vaccination is also available for high-risk children and adolescents who are vulnerable to infection due to conditions such as immunosuppression, chronic diseases, or cochlear implants. For high-risk children and adolescents, the vaccination schedule varies depending on their age at vaccination and previous vaccination history, so an individualized schedule must be followed. Notably, the upper age limit for high-risk children eligible for PCV20 support has been raised from 12 to 18 years. More children and adolescents will receive national immunization benefits. Pneumococcal conjugate vaccine (PCV) Immunization Procedure for Healthy Children. [Recommended months for the initial immunization]: Standard immunization at 2-6 months of age, 1) Primary series of Immunization: 2, 4, and 6 months of age (3 doses), 2) Booster dose: 12-15 months of age (1 dose). The inclusion of Prevenar 20 in the NIP is expected to intensify market competition. The sales of Prevenar 20 for pediatric and adolescent segments will continue to be handled by Korea Vaccine, which previously managed sales of Prevenar 13. It is widely analyzed that Pfizer Korea and Korea Vaccine, which have long maintained a dominant position with the existing 13-valent vaccine, will further expand their market dominance with the introduction of the 20-valent vaccine. Korea Vaccine is also preparing for on-site supply and is expected to aim for rapid market penetration by emphasizing the interchangeable vaccination guidelines and product advantages. An official from the vaccine industry stated, "An official from the vaccine industry stated, "As the NIP market for pneumococcal vaccines is being restructured, each company is actively preparing countermeasures," and added, "We believe Korea Vaccine's extensive experience will positively contribute to the rapid market establishment of Prevenar 20."
- Company
- Galafold reimbursed as first-line drug for Fabry disease
- by Nho, Byung Chul Aug 04, 2025 05:54am
- Reimbursement for Handok's Fabry disease treatment, Galafold (migalastat), will be expanded to cover its use as a first-line treatment starting on the first of this month. Previously, Galafold was covered only for patients aged 16 and older who had been administered enzyme replacement therapy (ERT) intravenously for at least 12 months. With this expansion of reimbursement, Galafold can now be prescribed as a first-line treatment without 12 months of enzyme replacement therapy. In addition, as stated in the approval, patients aged 12 years and older (weighing 45 kg or more) will be eligible for insurance reimbursement. Galafold is the world's first oral treatment for Fabry disease, developed by Amicus and supplied by Handok in South Korea. It is currently used in 45 countries, including the United States, the United Kingdom, Australia, Japan, and Europe, and was approved in Korea in 2017 and became listed for reimbursement in 2019. Unlike enzyme replacement therapy, which requires patients to visit the hospital once every two weeks for intravenous injections lasting several hours, Galafold is an oral treatment that patients can take themselves once every two days. This improves the convenience of medication administration and quality of life for Fabry disease patients. Galafold demonstrated a sustained and long-term safety profile in maintaining kidney function and reducing cardiac mass index when switching from enzyme replacement therapy to Galafold in Fabry disease patients with a compliant genotype, as confirmed by a 30-month long-term clinical trial. Additionally, in the switching group, cardiac adverse reactions occurred in 20% of patients receiving enzyme replacement therapy, but the rate decreased to 7% after switching to Galafold. Galafold demonstrated efficacy and safety not only in patients switching from enzyme replacement therapy but also in treatment-naive patients. In the Phase III FACET study, a 24-month clinical trial of Galafold in treatment-naive or enzyme replacement therapy-naive patients with Fabry disease harboring a compliant mutation, cardiac mass index decreased significantly from baseline, with a greater reduction in patients with left ventricular hypertrophy. (Overall: -7.7 ± 3.7 g/m², patients with left ventricular hypertrophy: -18.6 ± 8.3 g/m²) Additionally, in the long-term real-world patient registry study followMe , Galafold maintained stable renal function over an average treatment duration of 3.9 years, and that Fabry disease-related clinical events occurred in less than 80% of patients, confirming renal preservation and multi-organ benefits. Recently, the results of the ASPIRE study in pediatric patients were published in the May issue of the international academic journal ‘Molecular Genetics and Metabolism.’ The ASPIRE study showed that pediatric patients treated with Galafold maintained stable renal and cardiac markers, plasma lyso-Gb3 levels, and improvements in pain, gastrointestinal symptoms, and quality of life. Additionally, no new adverse reactions or unexpected safety issues were observed in the safety evaluation.
- Company
- Otsuka launches once-every-2-months inj 'Abilify Asimtufii'
- by Whang, byung-woo Aug 04, 2025 05:54am
- Product photo of Otsuka Pharmaceutical Korea announced on August 1 that it will launch 'Abilify Asimtufii Inj (aripiprazole monohydrate),' starting in August, as the reimbursement coverage by the National Health Insurance has been applied. 'Abilify Asimtufii Inj' is an extended-release formulation administered once every two months. It was approved on February 26 by the Ministry of Food and Drug Safety as a monotherapy for the treatment of schizophrenia and bipolar I disorder. A single administration can sustain a stable blood drug concentration for two months, thus it is expected to contribute to reducing the burden of medication and increasing treatment convenience in patients with psychiatric diseases. Abilify Asimtufii Inj is being launched as two dosages: 960 mg and 720 mg. The convenience of administration has been improved. For Abilify Maintena Inj, preparation before administration requires vigorous shaking for about 20 seconds after reconstitution. However, Abilify Asimtufii has been simplified, requiring only 10 gentle taps followed by shaking for 10 seconds, eliminating the need for a reconstitution process. Furthermore, similar to the existing 1-month prolonged-release injectable Abilify Maintena, patients stably taking oral aripiprazole can initiate treatment, or patients currently on Abilify Maintena can switch to Abilify Asimtufii on their next scheduled dose. A healthcare professional must administer it into the gluteal muscle. This formulation is an atypical antipsychotic drug that acts as a dopamine-serotonin system psychotropic agent. The efficacy of the drug was demonstrated in the treatment of schizophrenia and bipolar I disorder through partial agonism at dopamine D2 receptors and serotonin 5-HT1A receptors, and antagonism at serotonin 5-HT2A receptors. Sung-ho Moon, CEO of Korea Otsuka Pharmaceutical, said, "In the treatment of schizophrenia and bipolar I disorder, medication adherence is a crucial factor for patients' long-term prognosis, relapse prevention, recovery of social function, and improvement in quality of life," and added, "In Korea, medication adherence for psychiatric treatments is lower compared to other developed countries. Therefore, long-acting injectables will play an important role not only in therapeutic efficacy but also in improving adherence." Moon further added, "With Abilify Asimtufii, Otsuka Pharmaceutical Korea will actively support patients with schizophrenia and bipolar disorder in Korea to overcome their illnesses and improve their quality of life." Meanwhile, Abilify Asimtufii is currently used in over 26 countries, including the United States, Canada, the United Kingdom, and the EU.
- Policy
- MFDS clarifies support for advanced biopharmaceuticals
- by Lee, Hye-Kyung Aug 04, 2025 05:53am
- With the Ministry of Food and Drug Safety raising the approval and review fees for advanced biopharmaceuticals by up to KRW 410 million from January 1 this year, it has clarified the criteria for those eligible for fee reductions. In addition, detailed administrative disposition standards have been set for cases where human cell managers and cell processing facilities commit two or more violations. According to industry sources on the 1st, the MFDS recently re-announced its partial amendment to the Regulations on the Safety and Support of Regenerative Medicine and Advanced Biological Products and is collecting opinions. The revision includes the following provisions: ▲Integration of forms related to new drug fees (Appendix 4); ▲Clarification of fees for new drugs eligible for expedited processing; ▲Addition of supplementary provisions (application examples and transitional measures) to clarify the application of fee regulations; ▲Clarification of the wording of administrative disposition standards (Appendix 2). Specifically, the provision that previously stated that small and medium-sized enterprises would receive a 50% reduction in approval and review fees has been revised to require that the reduction be granted only if certain conditions are met. For fee reductions on new drug approvals, among advanced biopharmaceuticals designated for expedited review, the applicant must meet at least one of following conditions: ▲Manufacturers or entities that have filed a commissioned manufacturing and sales report in accordance with Article 23(3) of the Act, who have applied for product approval under Article 23(2) and (3) of the Act, customized review under Article 37(1), or conditional product approval under Article 38(1) of the Act. ▲Importer who has applied for an import license under Article 27(1) of the Act, customized review under Article 37(1), or conditional product approval under Article 38(1) of the Act For advanced biopharmaceuticals not designated for expedited review, fee reductions apply only when an applicant applies for marketing authorization under Article 23(2) and (3) of the Act. If the conditions for reduction are met, the fees for the approval and review of advanced biopharmaceuticals are set as follows: KRW 205 million for advanced biopharmaceuticals classified as new drugs requiring safety and efficacy reviews, KRW 123 million for those requiring reviews of manufacturing and quality control standards and test methods, and KRW 41 million for those requiring an evaluation of the implementation status of manufacturing and quality control standards. Additionally, the administrative disposition standards for cases involving two or more violations have been clarified as follows: “In cases where two or more violations have occurred, the most severe administrative penalty standard shall apply. However, if the administrative penalty standards correspond to the same business suspension, the most severe administrative penalty standard shall be applied, with half of each remaining administrative penalty standard added, provided that the maximum period does not exceed one year.” Meanwhile, in January, the MFDS raised the fees for new drug approval and preliminary review by about 50 times to KRW 410 million to strengthen the speed and expertise of new drug approval reviews. The revised fees apply to new drugs (including advanced biopharmaceuticals) and drugs that have been granted marketing authorization as orphan drugs and subsequently apply for conversion to new drug status (change approval). The review period is expected to be reduced from an average of 420 days to 295 days.
- Company
- Integrated CKM approach, the new paradigm for CKD treatment
- by Whang, byung-woo Aug 04, 2025 05:53am
- “In the past, we relied solely on single agents such as ACE inhibitors or ARBs to treat chronic kidney disease, but now an integrated approach that simultaneously manages cardiovascular, renal, and metabolic conditions is rising as the option. In this context, the results of the CONFIDENCE study, a recent study on the early combined use of SGLT-2 inhibitors and Kerendia, are drawing attention.” With new drugs being introduced for chronic kidney disease in people with diabetes, an area where there were relatively few treatment options, treatment strategies are also evolving. In particular, given that many kidney disease patients have comorbidities such as diabetes, obesity, and heart disease, there is a growing emphasis on the use of the cardio-kidney-metabolic (CKM) approach. Professor Prabir Roy-Chaudhury (President of the American Society of Nephrology )Professor Prabir Roy-Chaudhury, Drs. Ronald and Katherine Falk Eminent Professor and President of the American Society of Nephrology, emphasized the importance of treatment strategies that consider the close association between cardio-kidney-metabolic in a recent interview with Dailypharm. Professor Chaudhury emphasized the importance of an integrated approach to CKM because there are now methods available in the real-world that can significantly impact all three components of CKM. He explained, “It is rare for kidney disease patients to have kidney abnormalities alone; most have various comorbidities such as diabetes and obesity, making it essential to maximize treatment efficacy through an integrated CKD framework. In other words, a treatment that can influence all areas of CKM—kidneys, diabetes, and even obesity—has become important.” Emphasis on integrated CKM management... results of the CONFIDENCE study draw attention One of the drugs that has recently attracted attention as a core component of this integrated approach is Kerendia (finerenone). Kerendia is the first non-steroidal mineralocorticoid receptor (MRA) antagonist with a new mechanism of action that directly inhibits inflammation and fibrosis in the kidneys. In large-scale Phase III studies such as FIDELIO-DKD and FIGARO-DKD, Kerendia has been proven to inhibit kidney function decline and reduce the risk of cardiovascular events. Its reimbursement was approved in South Korea in February last year, leading to an increase in prescriptions. Professor Chaudhury said, “Kerendia is gaining attention as a new treatment strategy for chronic kidney disease in patients with type 2 diabetes due to its mechanism that directly targets kidney inflammation and fibrosis. It also shows potential to delay progression to dialysis.” Notably, the recently published CONFIDENCE study results demonstrated that early combination therapy with Kerendia and an SGLT-2 inhibitor significantly reduced proteinuria (UACR), presenting new possibilities in practice. The study results showed that when the two drugs were administered together, the urine-albumin-creatinine ratio (UACR) at 180 days after treatment initiation decreased by an average of 52% compared to baseline, showing a 29% greater reduction than the Kerendia monotherapy group and a 32% greater reduction than the SGLT-2 inhibitor monotherapy group. Professor Chaudhury said, “In the CONFIDENCE study, patients who received the combination therapy early on showed a 32% greater reduction in UACR at 180 days compared to the monotherapy group. These results demonstrate that early use of two drugs with different mechanisms of action can achieve greater efficacy in reducing albuminuria at six months.” He emphasized, “It is important to actively treat indicated patients with Kerendia from the early stages to reduce the urine-to-creatinine ratio (UACR).” Regarding safety concerns associated with the use of the combination of drugs, he said, “Combination therapy with the two drugs not only reduced proteinuria but also showed that it could be managed at an acceptable level when treatment approaches were tailored to individual patient characteristics.” Drug combination therapy opens a new treatment paradigm In particular, the main reason the professor is paying close attention to the results of the CONFIDENCE study is that he sees the potential for a “cure” for chronic kidney disease accompanied by diabetes. Professor Chaudhury said, “The key question to consider in the treatment of chronic kidney disease in people with diabetes is whether the combination of four classes of drugs can significantly reduce the number of patients progressing to end-stage kidney disease requiring dialysis or transplantation.” He added, “Just as we have entered an era where a cure is now a realistic possibility in cancer treatment, we have reached a stage where we can discuss the potential for cure in diabetes-associated chronic kidney disease through the combination of various medications.” He further emphasized, “From this perspective, the CONFIDENCE study is the first to bring us one step closer to our ultimate goal of a cure. It is particularly meaningful as the first study to demonstrate the potential of targeting different pathways to achieve the goal of a cure.” The significance of this study is that it provides direction for the simultaneous initiation of multiple classes of therapies and paves the way for their incorporation into future treatment guidelines. “Early diagnosis and improved access to treatment necessary for chronic kidney disease” Professor Chaudhury also stressed the need for improved disease awareness and education among patients, medical professionals, and the general public, as well as the importance of early diagnosis. He stated, “What is needed in all countries is education and improved awareness of the disease. We should not just check the kidneys when someone has diabetes or high blood pressure, but strengthen kidney disease screening for the entire population.” In particular, Professor Chaudhury emphasized that diabetes patients should regularly check albuminuria and eGFR from the time of diagnosis to monitor kidney damage early and intervene actively if abnormalities are detected. He explained, “Public health policies encompassing early diagnosis and improved access to treatment are necessary. Doctors, nurses, researchers, the pharmaceutical industry, insurers, and regulatory agencies must all work together.” Finally, he emphasized, “Proper use of new drugs is just as important as their development. The direction we should pursue is to actively disseminate and apply new treatment information to help patients maintain a healthy life without progressing to dialysis.”
- Company
- Rinvoq joins the competition in the alopecia areata trt. mkt
- by Whang, byung-woo Aug 04, 2025 05:53am
- AbbVie's JAK inhibitor Rinvoq (upadacitinib) is expected to enter the market competition following successful clinical trials for alopecia areata. Product photo of RinvoqAbbVie recently announced positive topline results from the No.2 study of the Phase 3 clinical program (UP-AA program) for Rinvoq in adult and adolescent patients with severe alopecia areata. In this trial, the primary endpoint has been met, with a significant increase in the proportion of patients achieving 80% or more scalp hair regrowth (the primary endpoint) at Week 24 compared to the placebo group. Based on these results, Rinvoq emerged as a strong candidate to join the alopecia areata treatment market. Specifically, 44.6% of patients in the Rinvoq 15mg arm and 54.3% in the Rinvoq 30mg group achieved 80% or more scalp hair regrowth (SALT score ≤20) at Week 24, compared to only 3.4% in the placebo group. Key secondary endpoints, including improved eyebrow and eyelash hair growth, achieving ≥90% scalp hair regrowth (SALT ≤10), and attaining complete scalp hair regrowth (SALT=0), were also met in both Rinvoq dose groups. The safety profile was largely consistent with what has been observed in existing Rinvoq indications, with no new safety signals identified. Arash Mostaghimi, Professor of Dermatology at Harvard Medical School and Brigham and Women's Hospital, said, "The sudden and often unpredictable hair loss experienced by patients with alopecia areata severely impacts their self-esteem and mental health," and added, "There is a desperate need for more therapies that help hair regrowth on the scalp and other areas. These results, showing the potential for upadacitinib to be an important new treatment option, are very favorable." Kori Wallace, the Vice President and Global Head of Immunology Clinical Development at AbbVie, stated, "UP-AA is the first pivotal clinical study to establish and achieve high goals such as SALT=0. These study results demonstrate AbbVie's commitment to advancing new therapies with the potential to improve the lives of patients with immune-mediated diseases." AbbVie plans to initiate global regulatory procedures based on these results. The clinical trial results announced included patients from Korea, suggesting that a swift approval process is anticipated. Third alopecia areata treatment is expected to emerge, and competition is anticipated If Rinvoq receives marketing authorization, it will become the third JAK inhibitor available in the domestic alopecia areata treatment market. Currently, two oral JAK inhibitors, Eli Lilly Korea's Olumiant (baricitinib) and Pfizer Korea's 'Litfulo (ritlecitinib),' can be used for the treatment of severe alopecia areata in Korea. Olumiant, approved by the Ministry of Food and Drug Safety (MFDS) in March 2023, became the first treatment for severe alopecia areata in adults in Korea. This drug was approved based on the results of the BRAVE-AA clinical trial, which showed that at 36 weeks, approximately 38.8% of patients receiving the 4 mg dose achieved 80% or more scalp hair regrowth, demonstrating superior efficacy compared to the placebo group (6.2%). Litfulo, the first alopecia areata treatment to gain an indication for adolescents aged 12 and older, received MFDS approval in September 2024 and was launched in Korea in March this year. In terms of mechanism of action, Olumiant simultaneously inhibits JAK1 and JAK2, while Litfulo selectively acts on JAK3 and TEC family kinases. The prevailing view in clinical settings is that sufficient data on treatment outcomes is needed for these two therapies, as a direct comparison is currently challenging. However, for adult patients, Olumiant could be considered for faster hair regrowth, while Litfulo might be preferred if safety concerns, such as the risk of infection, are prioritized. Compared to Olumiant, Litfulo is in the stage of accumulating prescription experience since its domestic launch, and its efficacy and safety profile in real-world patient populations will need further observation. (from left) Litfulo and Olumiant The late entrant Rinvoq is expected to join the market competition, backed by strong Phase 3 data. Rinvoq, as a selective inhibitor of JAK1, has a distinct target profile from existing drugs and is expected to appeal based on its proven efficacy and accumulated safety data from previous immune disease indications, such as atopic dermatitis. Notably, the high response rate of approximately half of the patients at week 24, confirmed in this trial, is expected to be a distinct strength in terms of short-term efficacy compared to competing drugs. Furthermore, adolescent patients were included in Rinvoq's global clinical trials, suggesting a high probability of securing an indication for ages 12 and older, similar to Litfulo, if approved in the future. This indicates that, in competition with Olumiant, which is limited to adult patients, Rinvoq will have a broader patient population. In competition with Litfulo, the experience accumulated in various indications, such as atopic dermatitis, will be a differentiating point. AbbVie has already successfully established Rinvoq as a treatment for atopic dermatitis in the dermatology field, leading to observations that it will effectively expand the alopecia areata indication to dermatology specialists, who are in the same prescribing group. In terms of treatment accessibility, the successive emergence of Olumiant and Litfulo in the field of alopecia areata, which previously had no approved treatments, marked a turning point in the treatment paradigm. With Rinvoq being introduced, the range of treatment options is expected to broaden further. However, the fact that alopecia areata cannot be reimbursed with the National Health Insurance and remains as the non-reimbursed drug is expected to be a barrier to market expansion.
- Company
- Janssen, Pharma distribution industry agree on margin adj
- by Son, Hyung Min Aug 01, 2025 06:18am
- The conflict between Janssen Korea and the pharmaceutical distribution industry over distribution margin reductions has been resolved with a negotiated settlement. The distribution industry achieved an outcome that maintains existing trade relationships, including with small and medium-sized distributors, while also improving the proposed margin reduction terms. Janssen Korea, in turn, reconfirmed its commitment to cooperation with the distribution industry, setting a precedent for mutual growth. According to industry sources, on August 1, the Korea Pharmaceutical Distribution Association recently announced that it has reached a final agreement with Janssen Korea regarding the reduction in distribution margin, following numerous negotiations. Notably, trade was maintained even for small and medium-sized distributors whose contracts were nearing expiration, and the entire distribution industry is deemed to have secured fair trade conditions without the involvement of the Fair Trade Commission. Previously, Janssen Korea had notified its distribution partners of a plan to pursue a two percentage point reduction from existing margins. While there were variations depending on individual contract terms, for example, a distributor with an existing 8% margin would see it adjusted to 6%. The distribution industry's position was that while some pharmaceutical companies had attempted margin adjustments of around one percentage point, a two percentage point adjustment was unprecedented. In response to this measure, member companies in Korea protested, standing firm and expressing their intent to refuse the distribution of Janssen products, stating that "they cannot handle products at a loss if margin cuts are enforced." In response, the Association immediately formed an emergency response committee and held several rounds of negotiations with Janssen Korea. Both sides narrowed their differences and finally formulated a negotiation proposal. While the specific details remain confidential, according to the Distribution Association, the distribution margins have been adjusted to an acceptable level, and trade terms that had burdened the distribution industry have been improved. The fact that small and medium-sized distributors whose contracts were expiring were not marginalized and could continue their business is considered a significant achievement. The pharmaceutical distribution industry and Janssen Korea officially convened a meeting to discuss distribution margin reductions. The Korea Pharmaceutical Distribution Association feels that this margin reduction conflict with Janssen Korea has strengthened its internal cohesion and external negotiation power. An official from the Distribution Association said, "Throughout numerous meetings, we conducted negotiations, conveying the strong voices of our member companies and the demand for mutual growth with the distribution industry. As negotiations continued, Janssen Korea, which had initially been unyielding, came to a consensus with the association and the distribution industry regarding the margin reduction, thus concluding the negotiations." Janssen Korea also issued a positive statement. The company said, "Through this negotiation, we were able to derive positive alternatives related to margin rates with our distribution companies," and added, "We thank the pharmaceutical distribution industry for their cooperation and are pleased to be able to continue a patient-centered collaborative relationship in the future." Park Ho-young, Chairman of the Korea Pharmaceutical Distribution Association, said, "This is the result of conveying the opinions of our member companies directly and not giving up until the end." He added, "While the outcome may not be entirely satisfactory for some member companies, the fact that we created an opportunity for mutual growth through the united strength of the distribution industry is positive." Park stated, "With margin reductions recurring over a long period, the distribution industry has already reached its acceptance limit," and added, "Pharmaceutical companies should refrain from easily resolving their management difficulties through margin adjustments."
- Policy
- ENT and pediatric departments prescribe the most drugs
- by Lee, Hye-Kyung Aug 01, 2025 06:16am
- Last year, medical institutions prescribed an average of 3.85 drugs per prescription. Outpatient clinics prescribed the most at 3.94, followed by hospitals at 3.88, general hospitals at 3.48, and tertiary hospitals at 3.10. The percentage of medical institutions prescribing 6 or more drugs increased by 0.79% from 18.34% in the previous year to 19.13%. These figures were released on the 31st by the Health Insurance Review and Assessment Service in its “2024 Drug Reimbursement Adequacy Assessment Results.” In the case of tertiary hospitals, the standard deviation in the number of drugs per prescription between institutions ranged from 2.60 at the lowest to 3.98 at the highest, indicating no significant difference. In contrast, clinics showed a range of 1.00 at the lowest to 8.89 at the highest, revealing a substantial difference. By age group, the number of drugs per prescription was highest for infants at 4.65, followed by children and adolescents at 4.25, adults at 3.75, and the elderly at 3.62. Among tertiary hospitals, the number of drugs prescribed for the elderly was the highest at 3.34, while general hospitals, hospitals, and clinics had higher rates for infants at 4.39, 4.90, and 4.62, respectively. The most common condition for medication prescriptions was acute lower respiratory tract infection, with 5.12 drugs prescribed per prescription. This was followed by acute upper respiratory tract infection at 4.77 and other upper respiratory tract disorders at 4.66. The number of drug items per prescription at clinics was 3.94, an increase of 0.03 from 3.91 in the previous year. By subject, the highest numbers were in otolaryngology (4.80), pediatrics (4.62), and general medicine/family medicine (3.97). By region, the ratio of the number of drug items per prescription was highest in Sejong (4.14%), then Incheon (4.04%), then Jeonbuk (4.03%), and lowest in Daegu (3.82%), then Seoul and Daejeon (3.85%). The prescription rate for 6 or more items was 18.143%, with tertiary general hospitals at 13.08%, general hospitals at 15.25%, hospitals at 19.02%, and clinics at 19.19%. Among clinics, 18,317 institutions (54.53%) had a prescription rate of 10% or less for six or more items, which was the highest number, and the ratio decreased by 0.99% compared to the previous year. Institutions with a rate of 40% or higher for prescribing six or more items accounted for 2,063 institutions (6.14%), with the highest rates observed in otolaryngology (29.22%) and pediatrics (20.76%) departments. The antibiotic prescription rate for acute upper respiratory tract infections was 45.20%, with tertiary general hospitals at 7.15%, general hospitals at 34.67%, hospitals at 53.60%, and clinics at 44.87%. Compared to the previous year, the rate increased the most in clinics (increased 3.97 percentage points). The number of institutions with an antibiotic prescription rate for acute upper respiratory tract infections below 10% was the highest at 3,320 (22.26%), a decrease of 3.23 percentage points compared to the previous year. The number of institutions with an antibiotic prescription rate for acute upper respiratory tract infections of 70% or higher was 2,338 (15.67%). The antibiotic prescription rate for acute upper respiratory infections at clinics was 44.87%, with the highest rates in otolaryngology (51.76%), pediatrics (46.07%), and general medicine (42.72%). By region, the rates were highest in Gwangju (50.23%), Chungnam (49.05%), and Chungbuk (47.97%), and lowest in Ulsan (42.06%), Daejeon (42.20%), and Seoul (42.50%). The antibiotic prescription rate for acute lower respiratory tract infections was 61.86%, with 21.73% at advanced general hospitals, 48.84% at general hospitals, 59.55% at hospitals, and 62.29% at clinics. The antibiotic usage per patient was 1,837.9 DDD for acute upper respiratory tract infections, 2,672.5 DDD for acute lower respiratory tract infections, and 2,463.0 DDD for respiratory diseases.
- Policy
- PPP also proposes free HPV vaccination for ppl under 26
- by Lee, Jeong-Hwan Aug 01, 2025 06:16am
- Following the ruling party, the main opposition party, the People Power Party, also submitted a bill to the National Assembly to provide free HPV vaccines to all citizens aged 26 and under, regardless of gender. The People Power Party’s bill also included provisions to expand the scope of free influenza vaccinations beyond the current coverage. This would involve increasing the age eligibility for influenza vaccines under the National Immunization Program (NIP), which was previously only applied to children, adolescents, and the elderly. Currently, three types of HPV vaccines are approved in South Korea: Cervarix (bivalent), Gardasil (Quadrivalent), and Gardasil 9 (9-valent). If the legislation is passed, the expansion of the scope of NIP is expected to bring positive outcomes. Currently, only Cervarix and quadrivalent Gardasil are included in the NIP, but the demand for Gardasil 9’s inclusion in the NIP will likely grow if the legislation is enacted. On the 31st, People Power Party member Mi-ae Kim introduced a bill to amend the Infectious Disease Control and Prevention Act to include these provisions. Expanding eligibility for free HPV vaccinations to both men and women was a common campaign promise of both the ruling and opposition parties in the last presidential election. Until now, only the ruling party had submitted related bills to the National Assembly (by Reps. Hee-seung Park and Sujin Lee), but with Rep. Mi-ae Kim introducing a bill with the same intent, the legislation is gaining momentum. Rep. Kim pointed out that HPV is a virus that can cause various diseases, including cervical cancer, anal cancer, and oral cancer, and can affect both men and women. However, she said that the issue is that the current NIP is limited to “women aged 12 to 26.”. To address this, Rep. Kim introduced a bill to include anyone under the age of 26, regardless of gender, in the free HPV vaccination program. In addition, Rep. Kim’s bill includes a provision to expand the scope of free influenza virus vaccinations. Currently, the NIP (free vaccination) for influenza vaccines is limited to “pregnant women, children aged 13 and under, and seniors aged 65 and over.” In the bill, Representative Kim expanded the scope of free influenza vaccinations to “those aged 18 and under and those aged 62 and over.” Rep. Kim explained, “Considering that most children engage in group activities at school until around the age of 18, it is necessary to extend the age range for vaccination to 18 to more thoroughly prevent the spread of the influenza virus. In addition, vaccination support for the elderly, who are vulnerable to influenza, must be strengthened further.” Meanwhile, the Democratic Party of Korea has proposed swift passage of bills related to the common campaign pledges of both parties during the presidential election to PPP and other opposition parties, which include free HPV vaccinations for both men and women.
