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- 2026-04-21 15:18:27
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- RNAi 'Amvuttra' to enter the final reimb process soon
- by Eo, Yun-Ho Jan 13, 2026 06:58am
- The RNAi therapeutic 'Amvuttra' is facing its final hurdle in insurance reimbursement listing process.According to sources, the Ministry of Health and Welfare (MOHW) recently ordered a drug price negotiation to the National Health Insurance Service (NHIS) for Amvutra (vutrisiran). Amvutra is a new treatment for hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN), developed by Alnylam Pharmaceuticals and introduced to the Korean market by Medison Pharma Korea.Accordingly, discussions are expected to begin once the NHIS negotiation team is formed. Amvutra previously passed the Health Insurance Review and Assessment Service's (HIRA) Drug Reimbursement Evaluation Committee in December last year.Amvutra was designated as an orphan drug by the Ministry of Food and Drug Safety (MFDS) in November 2023 and received final approval in November last year.Amvutra is administered by subcutaneous injection once every 3 months. This drug targets and silences specific messenger RNA (mRNA) to block the production of both wild-type and mutant transthyretin (TTR) protein.The efficacy of Amvutra was demonstrated through the HELIOS-A Phase 3 study. The Phase 3 trial enrolled 164 hATTR-PN patients with polyneuropathy across 22 countries. These patients were randomly assigned to either the Amvutra group (122 patients), receiving 25mg via subcutaneous injection every three months, or the 'Onpattro (patisiran)' group (42 patients), receiving 0.3mg/kg via intravenous injection every three weeks.Amvutra's efficacy was assessed by comparing its data with placebo data from the APOLLO study, which evaluated the efficacy and safety of Onpattro in a patient population similar to that in HELIOS-A.As a result, during the 9-month treatment period, the Amvutra group experienced less severe neurological impairment and showed improved quality of life compared to the placebo group. In the 10-meter walk test, which assesses a patient's walking speed and motor ability, the time taken by the vutrisiran group showed almost no change. NT-proBNP, a biomarker used to evaluate cardiac function, also showed improvement.Meanwhile, hATTR-PN, which affects approximately 1 in 100,000 people, is a disease caused by mutations in the transthyretin gene. It is characterized by systemic multiple autonomic neuropathies, including cardiac, gastrointestinal, and ophthalmic. Vyndaqel stabilizes the transthyretin protein.Generally, symptoms such as pain, paresthesia, and paralysis begin in the lower extremity nerves, where abnormal proteins tend to accumulate, eventually spreading to the upper body and affecting other organs, such as the heart, kidneys, and eyes. Life expectancy is 7 to 12 years on average from the onset of symptoms.
- Company
- Ferring and Hanmi to co-market Minirin and Nocdurna
- by Kim, Jin-Gu Jan 13, 2026 06:58am
- Ferring Korea and Hanmi Pharmaceutical will jointly market the desmopressin-based nocturia-enuresis treatments Minirin Tab and Nocdurna Sublingual Tab.On the 12th, the two companies announced that they had signed a co-marketing agreement for the two products. Under the agreement, Ferring Korea will be responsible for sales and marketing at general hospitals, while Hanmi Pharmaceutical will oversee sales and marketing at small-to-mid-sized hospitals with fewer than 300 beds, as well as clinics from January this year. All domestic distribution will be handled by Hanmi Pharmaceutical.Minirin is a synthetic analogue of the antidiuretic hormone vasopressin that works by reducing nighttime urine production and is used to alleviate nocturia symptoms. It is the standard treatment for primary nocturnal enuresis in children (aged five and older) and is also used to improve symptoms associated with nocturnal polyuria, a major cause of adult nocturia.Nocdurna is a low-dose sublingual tablet formulation of Minirin developed for the treatment of adult nocturia. It is designed to reduce the risk of hyponatremia, which is of particular concern in elderly patients. The sublingual formulation also improves medication convenience and bioavailability.Min-jung Kim, CEO of Ferring Korea, said, “This new partnership with Hanmi Pharmaceutical will further solidify the market leadership of Minirin and Nocdurna, which currently hold the No.1 market share, and enable their stable provision to more patients.”Jae-hyun Park, CEO of Hanmi Pharmaceutical, commented, “We are very pleased to be able to provide clinically validated nocturia symptom treatments to Korean patients through our partnership with Ferring Korea. Leveraging Hanmi’s extensive hospital network and field expertise, we will strive to ensure more patients experience the clinical benefits of Minirin and Nocdurna.”
- Company
- MenQuadfi emerges…SK-Sanofi shakes up meningococcal vacc mkt
- by Hwang, byoung woo Jan 13, 2026 06:58am
- The competition for next-generation vaccines has begun as SK Bioscience, in partnership with Sanofi, launches the next-generation meningococcal vaccine, MenQuadfi, into the market.The key differentiator for MenQuadfi is that it can be administered from as early as 6 weeks of age, significantly expanding the vaccination age for infants compared to existing products. This is viewed as a strategic move to secure portfolio leadership by preoccupying the early stages of the pediatric vaccination schedule.Product photo of MenQuadfiSK Bioscience recently cooperated with Sanofi's Korean subsidiary to launch the quadrivalent meningococcal conjugate vaccine 'MenQuadfi (MenACWY-TT).'MenQuadfi is a vaccine that can be administered to individuals aged 6 weeks to 55 years, preventing invasive meningococcal disease (IMD) caused by the major meningococcal serogroups A, C, W, and Y.It was initially authorized for ages 2 and older, then its indications were expanded at the end of August last year to include infants from 6 weeks to under 2 years of age, based on the results of the MET42 and MET61 studies.MenQuadfi contains 10μg of antigen for each of the four meningococcal serogroups (A, C, W, and Y). User convenience of this drug was improved as a fully liquid formulation that can be administered immediately without the need for separate dilution or mixing.Among the A, C, W, and Y meningococcal vaccines approved in Korea, MenQuadfi is the only product that includes serogroup A and can be used for infants aged 6 weeks to under 24 months. SK Bioscience will be responsible for the domestic distribution and supply for infants and children.Meningococcal infection is transmitted through respiratory secretions such as nasal mucus or saliva and can even be transmitted by asymptomatic carriers. Consequently, major countries such as the U.S., U.K., Australia, and Canada include meningococcal vaccines in national immunization programs or operate them as routine vaccinations based on official recommendations, focusing on infants, children, and adolescents.In Korea, the Korea Disease Control and Prevention Agency (KDCA) recommends vaccination for high-risk groups, including immunocompromised individuals, laboratory workers, new military recruits, university dormitory residents, those traveling to or staying in endemic areas, and contacts during an outbreak.Currently, the meningococcal vaccine market in Korea is relatively small. As of 2023, based on IQVIA data, the total market size is less than KRW 10 billion.The competitor the SK Bioscience and Sanofi joint force must overcome is GSK. Before the launch of MenQuadfi, Sanofi had a meningococcal vaccine called Menactra. Still, its market share was smaller than that of Menveo, GSK's vaccine against invasive meningococcal disease caused by serogroups A, C, W, and Y, which offers the same preventive effects (vaccination ages differ).GSK is currently targeting the market through a two-track vaccination strategy using Bexsero, a multicomponent meningococcal group B vaccine launched in 2024, and Menveo.Sanofi has decided to withdraw Menactra alongside the launch of MenQuadfi. In a situation where the market is small and a next-generation vaccine with broader protection has emerged, the company has concluded that there is no need to maintain a vaccine with the same level of protection. Regarding the exact timing of discontinuing Menactra supply, the company stated it remains flexible, depending on the market inventory.From SK Bioscience, which is in charge of domestic distribution and supply, it is expected to employ a strategy to increase market share through competition with GSK while maintaining its existing Menactra market.Positive aspects also exist. Through MenQuadfi, SK Bioscience has added another domestic distribution collaboration product with Sanofi to its market lineup.According to SK Bioscience's IR materials, the company is engaged in extensive cooperation ranging from National Immunization Program (NIP) vaccines to premium vaccines, including the pediatric 6-in-1 DTaP vaccine Hexaxim, the adult Tdap vaccine Adacel, and the RSV antibody Beyfortus.Following Hexaxim's entry into the NIP and the introduction of Avaxim in 2025, distribution performance for Sanofi-related vaccines rose from KRW 7.5 billion in the third quarter of 2024 to KRW 11.1 billion in the third quarter of 2025.Given that Beyfortus has begun full-scale operations for the winter season, these results are expected to grow further in 2026.The company plans to strengthen a preemptive prevention strategy against major pediatric infectious diseases based on its portfolio that includes both vaccines and preventive antibodies.In terms of R&D, this collaboration is predicted to strengthen further, as the company is currently in Phase 3 development of a 21-valent pneumococcal vaccine with Sanofi.Jaeyong Ahn, CEO of SK Bioscience, stated, "With the introduction of MenQuadfi, the options for preventing invasive meningococcal disease in infants and children in Korea have expanded," adding, "We will strengthen the infectious disease prevention setting based on global partnerships and continue to supply vaccines that can contribute to public health."
- Company
- Support for official academic conferences begins in July
- by Kim, Jin-Gu Jan 12, 2026 03:58pm
- Support for name-only 'international academic conferences' will be blocked. Starting in July, support will only be available for conferences recognized by professional associations, including the Korean Medical Association and the Korean Pharmaceutical Association.When supporting an academic conference, the overlapping provision of additional food and beverages, booth rentals, and advertisements is prohibited. Promotional materials at booths are limited to pens and notepads valued at KRW 10,000 or less. Exposing product names is prohibited, while exposing company names is permitted.The Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) recently received approval from the Fair Trade Commission for 'Code of Fair Competition for Pharmaceutical Trade (5th revision).' The revised Fair Competition Code focuses on blocking various 'pseudo-academic conferences' that pose as academic meetings and on the practice of indirect support. Evaluations suggest that this revision has clarified the boundaries between academic conferences, product presentations, and exhibitions·advertisements, effectively putting the brakes on support methods that utilize product presentations and satellite symposia during academic conferences.◆Blocking formality-only international events = The revised Fair Competition Code has established a new definition for 'internationally held academic conferences in Korea.' To use the title of an international academic conference, the event must pass the screening criteria set by medical and pharmaceutical associations. The screening criteria must include: ▲ number of foreign participants ▲ the level of internationalization of the conference program ▲ the number of annual applications, and ▲ the level of substance in the conference program.Additionally, the event must be held in Korea as an international-scale conference for at least 2 days, with on-site attendance from at least five countries and 50 or more foreign healthcare professionals (excluding those whose attendance is supported by the organizer or invited speakers). Furthermore, budget and settlement details must be submitted to the KPBMA. However, international conferences on rare diseases need only meet either the five-country or the 50-person requirement.The KPBMA will give prior notice requiring the submission of cost settlement details and other supporting documents within 90 days after the event ends to verify whether the international conference held in Korea was conducted in accordance with the plan. If the conference organizing body refuses, the KPBMA is authorized to suspend the conference support process.As there have been many cases that seemed international conferences but were in fact closer to domestic academic events, the codification of these standards is interpreted as a mechanism to filter out formality-only or expedient international events.◆Prohibition of splitting support for academic conferences = Methods for supporting the hosting and operation of academic conferences have also become stricter. When a pharmaceutical company sponsors a conference, it cannot provide overlapping ▲ donations ▲ food and beverages ▲ booth rentals ▲ advertisements related to that conference.Product presentations held during an academic conference are not recognized as 'separate events.' The new code clarifies that product presentations held during a conference are considered part of the conference and must be supported by Articles 8 and 9, which govern academic conferences.Accordingly, it has become virtually impossible to separate and provide independent support for satellite symposia or luncheon sessions held during the conference period as product presentations.This is interpreted as an intent to block overlapping or roundabout support during the conference period. Organizations hosting academic conferences must apply for support to the KPBMA at least 90 days before the event. If there is a potential violation, the KPBMA can demand an explanation or correction, and if not implemented, it can suspend the support process.◆New standards for booth fees limiting 'maximum KRW 3 million' = New standards regarding the operation of exhibition and advertising booths have been established. Booth fees for academic conferences hosted by academic societies range from KRW 2 million to 3 million per instance. In comparison, conferences hosted by medical institutions are set at KRW 500,000 to KRW 1 million per instance. However, booth fees may be adjusted considering inflation rates, etc., in which case they must undergo prior review by the Fair Trade Commission.Academic conferences eligible for booth fee payments are limited to events that provide three or more medical·pharmaceutical continuing education credits (minimum 3 hours) and are attended by 50 or more healthcare professionals (25 for rare disease societies).◆Promotional materials limited to 'pens and notepads' = Standards for promotional materials related to a company's own product presentations have also been strengthened. In principle, no items of value other than food and beverages can be provided. As an exception, only pens and notepads are permitted.In this case, the combined value of the pen and notepad cannot exceed KRW 10,000, in accordance with Appendix 2 of the Enforcement Rule of the Pharmaceutical Affairs Act. Labeling product names on pens and notepads is prohibited. However, company names may be labeled.◆Clarifying meal and transportation costs = Standards for meal and transportation costs for conference participants have become clearer. For domestic conferences, support for up to 3 meals per day can be provided, depending on the number of days attended. Receipts for payments made with a personal card or in cash at restaurants within the hosting region must be provided as evidence. The support limit per meal is KRW 50,000, with actual cost reimbursement.For overseas conferences, meal costs have been fixed by grade and country and city in accordance with the REGULATIONS ON TRAVEL EXPENSES FOR PUBLIC OFFICIALS. They are categorized into Grade A (KRW 100,000 per day), Grade B (KRW 80,000), Grade C (KRW 60,000), and Grade D (KRW 50,000).Standards for supporting local transportation costs for overseas conferences have also changed. Previously, up to KRW 150,000 could be supported based on actual travel costs, such as airport-to-hotel or accommodation-to-venue. Following the revision, a fixed amount of KRW 100,000 can be supported per academic conference.The blocking of formality-only international events, the prohibition on split support for conferences, and the new standards for booth fees will take effect on July 1 of this year. The limitation of promotional materials to pens and notepads, as well as the details regarding meal and transportation costs, have been in effect since January 1 of this year.In addition, this revision reflects new content regarding CSOs and the expenditure report system following revisions to related laws. A new provision requires pharmaceutical companies to prepare and disclose expenditure reports on the details of economic benefits provided to pharmacists, Asian pharmacists, medical professionals, founders of medical institutions, or employees of medical institutions within three months after the end of the fiscal year, and to retain the relevant expenditure reports, ledgers, and supporting data for five years.The definition of pharmaceutical sales promoters now includes not only pharmaceutical suppliers as defined in the Pharmaceutical Affairs Act (i.e., those who have received pharmaceutical product licenses, importers, or pharmaceutical wholesalers) but also "those entrusted with pharmaceutical sales promotion business and those sub-entrusted by them." It has been specified that CSO companies entrusted with sales representation by pharmaceutical companies or wholesalers can also be subject to the promotion business regulations of the Fair Competition Code.
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- Average finished product output rises, but fewer products
- by Chon, Seung-Hyun Jan 12, 2026 03:58pm
- The average finished drug production value of pharmaceutical companies is showing a continued upward trend. With an increase of more than 20% compared to four years ago, average output per company has now surpassed KRW 70 billion. At the same time, the average number of products manufactured by each company has declined, suggesting that firms are gradually moving away from a “department-store-style” business model based on mass small-volume production. Companies with production volumes under KRW 10 billion accounted for half of the total, indicating a significant proportion of small-scale pharmaceutical firms.According to the 2025 Food and Drug Statistical Yearbook released by the Ministry of Food and Drug Safety (MFDS) on January 10, 403 pharmaceutical companies produced KRW 28.4623 trillion worth of finished drugs in 2024, with average production per company reaching KRW 71.2 billion.Average finished drug production value (left, KRW million) and number of products (right, %) (Source: MFDS)The average production value per pharmaceutical company has risen every year.In 2014, pharmaceutical companies produced an average of KRW 47.8 billion worth of products, expanding by 49.0% over the decade. The average production value per company has increased for four consecutive years since reaching KRW 53.2 billion in 2020. Over the past four years, it rose by 33.7%, surpassing KRW 70 billion for the first time.This expansion in average production value is analyzed as a result of the pharmaceutical industry's sustained growth as a whole. Total finished drug production value increased by 99.3%, from KRW 14.2805 trillion in 2014 to KRW 28.4623 trillion in 2024. During the same period, the number of finished drug manufacturers increased by 33.8%, from 299 to 400. As production growth far outpaced the increase in the number of companies, average output per company expanded significantly.In contrast, the number of finished drug products manufactured per company has clearly declined.In 2024, pharmaceutical companies produced an average of 51.3 finished drug products each, down 2.1 products from the previous year. The average stood at 53.4 products in both 2022 and 2023.In 2014, companies manufactured an average of 61.4 products, meaning the figure has fallen by more than 10 products over the past decade. This suggests that firms are gradually moving away from a “department-store-style” business model based on numerous low-revenue products and are instead pursuing structural reform.In 2024, the average production value per finished drug product reached KRW 1.387 billion, up 11.0% year-on-year. Over the past 10 years, the figure has increased by 80.1% from KRW 778 million in 2014. Industry observers interpret this as evidence that pharmaceutical companies are restructuring their product portfolios and pursuing a strategy of selection and concentration, reducing the number of products while improving profitability—marking a clear shift toward structural reform.Number of companies by finished drug production scale (Source: MFDS)Looking at the status of companies by finished drug production scale, small pharmaceutical companies with annual production value under KRW 10 billion accounted for a large proportion.In 2024, 205 companies recorded annual production of less than KRW 10 billion, representing 51.3% of all manufacturers. This represents an increase of 85 companies from the 140 companies below KRW 10 billion in 2014, with their share rising by 4.5 percentage points from 46.8%. In 2019, companies with production value below KRW 10 billion numbered 181, accounting for 51.9%.As of 2024, the largest group consisted of companies with annual production of less than KRW 1 billion, totaling 121 firms. This was followed by 56 companies with production between KRW 1 billion and KRW 5 billion, and 28 companies with production between KRW 5 billion and KRW 10 billion.The number of companies producing less than KRW 1 billion annually more than doubled over the past decade, rising from 51 firms in 2014. However, this segment peaked at 137 companies in 2020 before declining by 12 companies over the following four years.In contrast, large pharmaceutical companies have shown a steady increase. Firms with annual finished drug production of KRW 500 billion or more were just five in 2014, but more than doubled to 13 companies over the past decade. The number of companies with production exceeding KRW 500 billion remained at five through 2017, increased to six in 2018 and 2019, rose to eight in 2021, and surpassed ten from 2022 onward. In 2022, 11 companies recorded production of more than KRW 500 billion, with one additional company added each year for two consecutive years.
- Company
- Isturisa, first and only Cushing's syndrome drug, prescribed
- by Eo, Yun-Ho Jan 12, 2026 03:57pm
- The new treatment for Cushing's syndrome 'Isturisa' is becoming available for prescription at general hospitals. According to industry sources, Isturisa (osilodrostat), Recordati Korea's treatment for adult Cushing’s disease, has passed the Drug Committees (DC) reviews at several medical institutions, including Sinchon Severance Hospital, Ajou University Hospital, and Chonnam National University Hwasun Hospital.Additionally, the landing process is underway at other major tertiary hospitals, such as Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, and Asan Medical Center.Following its inclusion on the insurance reimbursement list last December, the drug appears to be gradually expanding its prescription areas.Cushing's disease is a rare and chronic hormonal disorder caused by a benign pituitary tumor that secretes excessive amounts of adrenocorticotropic hormone (ACTH).If a patient is exposed to high cortisol levels over a long period due to excessive ACTH secretion, morbidity and mortality increase, and various systemic symptoms such as cardiovascular and metabolic diseases, psychiatric disorders, fractures, and osteoporosis occur.The main treatment goals for patients with Cushing's disease are the rapid and sustained normalization of cortisol levels to improve physical signs and comorbidities and to enhance the patient's quality of life.However, about one in three patients with Cushing's disease experiences recurrence or is not fully cured even after pituitary surgery, necessitating additional treatment. For these patients with persistent or recurrent Cushing's disease, drug therapy to lower cortisol levels is recommended, and Isturisa is currently the only drug approved in Korea for the treatment of Cushing's disease.Isturisa demonstrated efficacy through the LINC3 and LINC4 Phase 3 studies, which involved patients with persistent or recurrent Cushing's disease who had previously relapsed after pituitary surgery or radiation therapy, or for whom surgery was not possible.As a result of the research, in the LINC3 study, 86% of patients who continued Isturisa administration at week 34 achieved a complete response (CR) with mUFC levels below the ULN. In comparison, only 29% of patients who switched to placebo after 24 weeks of Isturisa administration achieved a CR.In the LINC4 study, 77% of the Isturisa group and 8% of the placebo group achieved CR at week 12. Furthermore, in the LINC3 extension study, 81% of patients who were administered Isturisa up to week 72, and in the LINC4 extension study, 72.4% of patients who were administered Isturisa up to weeks 72 to 96, consistently achieved CR.A Recordati official stated, 'Recordati is actively promoting the landing of Isturisa in major medical institutions so that Korean Cushing's disease patients, who have struggled to regulate their cortisol levels within the normal range, can receive the treatment benefits of Isturisa quickly, as it is the only drug approved in Korea for the treatment of Cushing's disease.'
- Company
- Atopic dermatitis drug 'Ebglyss' enters tertiary hospitals
- by Eo, Yun-Ho Jan 09, 2026 08:36am
- Ebglyss (lebrikizumab)'Ebglyss,' a new atopic dermatitis treatment, has entered the 'Big 5' tertiary generic hospitals.According to industry sources, Lilly Korea's interleukin (IL)-13 inhibitor Ebglyss (lebrikizumab) has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center in Seoul, and Sinchon Severance Hospital, as well as medical institutes, including Korea University Anam Hospital and Seoul National University Bundang Hospital.After Ebglyss was included in the insurance reimbursement listing in July, the prescription areas for this drug have expanded rapidly.Ebglyss is a new biologic that selectively blocks cytokine IL-13, a primary cause of atopic dermatitis. Ebglyss was approved in August 2024 for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older (weight over 40kg) who are not adequately controlled by topical therapies or for whom these therapies are not recommended.Existing atopic dermatitis treatments include Dupixent, which inhibits IL-4 and IL-13, JAK inhibitors like Rinvoq, and Adtralza, which targets IL-13. The emergence of Ebglyss further expands the range of treatment options. As atopic dermatitis is a chronic disease that is difficult to cure and requires long treatment periods, a wide range of therapeutic options is essential.The efficacy and safety of Ebglyss have been confirmed through Phase 3 clinical studies, including ADvocate-1, ADvocate-2, and ADhere.In ADvocate-1 and ADvocate-2, which evaluated Ebglyss monotherapy, the Ebglyss group showed Eczema Area and Severity Index (EASI)-75 rates of 58.2% and 52.1%, respectively, during the induction period (weeks 0-16), representing an improvement over the placebo group (16.2% and 18.1%). EASI-90 rates for the Ebglyss groups were 38.3% and 30.7%, respectively, while placebo groups remained at 9% and 9.5%. EASI is the percentage improvement in eczema severity.Furthermore, after one year of maintenance therapy, the Ebglyss group's EASI-75 achievement rate at week 52 was 81.7%, and the EASI-90 rate was 66.4%. These figures were higher than those of the placebo group, at 66.4%.According to Korea's atopic dermatitis guidelines, systemic treatment is strongly recommended for patients with moderate-to-severe atopic dermatitis. However, while the proportion of moderate-to-severe atopic dermatitis patients in Korea increased from 30.9% to 39.7% between 2002 and 2019, the prescription rate of systemic immunosuppressants in this patient group remained at only 5%.
- Company
- Rep. Soo-jin Choi, ‘Why lower drug prices for usage increases?’
- by Kim, Jin-Gu Jan 09, 2026 08:36am
- Rep. Soo-jin Choi of the People Power Party (member of the National Assembly’s Science, ICT, Broadcasting and Communications Committee) sharply criticized the price-volume linkage system at the pharmaceutical industry’s New Year reception.She pointed out that a structure lowering drug prices solely because usage increased is far removed from alleviating the public's medical expense burden and could instead undermine the supply base for generic drugs and the foundation of Korea’s pharmaceutical and biotech industry.Choi made these remarks while delivering a New Year's address at the 2026 Pharmaceutical New Year's Reception hosted by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) on the 7th. She began, “I'd like to take this opportunity to say this. I still don't understand why drug prices are linked to usage volume.”She continued, “The drugs that can be supplied to the public without burden are affordable generics. New drugs, on the other hand, are truly expensive. Setting generic drug prices below KRW 100 is essentially telling manufacturers not to produce them.”She also assessed that the price reduction tied to increased usage is overly driven by fiscal logic.Choi criticized, “Lowering prices even for medicines whose increased usage allows them to be supplied more affordably to the public is an approach that looks only at numbers and National Health Insurance finances.”She emphasized, “If the industry cannot develop solely because of fiscal consolidation, the Korean pharmaceutical industry will ultimately lose its competitiveness. Drug price reductions must be approached very cautiously and from a holistic perspective.”Regarding institutional reform, she urged the government to conduct a thorough review, adding, “It is time to form an expert panel and build a realistic system that allows high-quality medicines to be supplied to the public at appropriate prices.”
- Company
- Diverging views on pricing reform surface at New Year gathering
- by Kim, Jin-Gu Jan 09, 2026 08:36am
- The 2026 Pharmaceutical New Year's Reception was held with the attendance of approximately 200 key figures from the government, National Assembly, and pharmaceutical industry. Amidst New Year's greetings and presentations of industry visions, differing perspectives on the government's ongoing drug pricing system reform were once again evident throughout the event.The Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) and the Korean Pharmaceutical Association (KPA) expressed concerns about the potential industrial impact and on-site confusion resulting from the drug pricing system reform. In contrast, the government and ruling party reaffirmed the fundamental direction of the drug pricing system reform and stated their commitment to pushing forward its implementation.In his welcome address, KPBMA Chair Yunhong Noh identified the drug pricing reform as a pending issue that may seriously affect the entire industry.Noh stated, “The drug pricing system reform is an issue that could shake the very foundation of Korea's pharmaceutical and biotech industry. Rather than pushing ahead the government's set schedule, the reform must be redesigned through consultation with industry stakeholders to strike a balance between public health, industrial growth, and pharmaceutical expenditure.” His remarks were interpreted as a clear call for adjusting the pace of reform and supplementing or recalibrating the system.The Korean Pharmaceutical Association also expressed concern over confusion in the field. Young-hee Kwon, President of the Korean Pharmaceutical Association, said, “Large-scale drug price cuts implemented earlier this year are expected to cause significant confusion across pharmacies. To reduce recurring confusion and improve policy effectiveness, the government must prepare clear institutional alternatives. Practical adjustments are necessary, such as addressing inventory claims and settlement issues.”The Ministry of Health and Welfare explained the direction of the drug pricing system reform as ‘rewarding innovation and ensuring stable supply,’ and reaffirmed its commitment to continue the push.Hyung-hoon Lee, Vice Minister of Health and Welfare, stated, “We will pursue improvements to the drug pricing system to sufficiently reward the value of innovation and ensure the stable supply of essential medicines. We will support the pharmaceutical and biotech industry’s evolution into a more innovation-oriented ecosystem.”Meanwhile, Yu-kyoung Oh, Minister of Food and Drug Safety (MFDS), pledged regulatory support amid a changing regulatory environment. Oh said, “This year will mark the first year of a major transformation in pharmaceutical regulatory services. We will increase the speed and efficiency of reviews by expanding review personnel and introducing an AI-based review support system.”Ruling party lawmakers largely defended the policy direction of drug pricing reform.Yoon Kim, a lawmaker from the Democratic Party of Korea, emphasized, “Drug pricing reform should not be viewed simply as a policy aimed at cutting prices to reduce National Health Insurance spending. It is part of a broader effort to transform the pharmaceutical and biotech industry into an innovative ecosystem that has global competitiveness.”Kim added, “Of course, I am fully aware that there are significant concerns raised in the field. However, if we share the common goal of elevating Korea's pharmaceutical industry to a global level, we can sufficiently discuss and adjust the pace and details of the system. At the National Assembly level, we will reflect the voices from the field and play our role to ensure that the drug price adjustment policy leads to industrial innovation.”Rep. Young-seok Seo, also of the Democratic Party of Korea, remarked, “While various institutional challenges exist, the ultimate criterion for judgment is the public's right to health. We must find solutions within the broader framework of public health.”Opposition lawmakers were generally more critical of both the current pricing system and the government’s reform direction.Rep. Soo-jin Choi of the People Power Party, referring to the price-volume linkage system, pointed out, “The drugs that can be supplied to the public without burden are affordable generics. Setting generic drug prices below KRW 100 is effectively telling manufacturers not to produce them.”Choi further emphasized, “Lowering the price of drugs that can be supplied more cheaply to the public simply because they are high-volume is an approach focused solely on numbers and the NHIS budget. If industry development is sacrificed solely for fiscal soundness, Korea’s pharmaceutical industry will ultimately lose competitiveness. Drug price reductions must be approached very cautiously and from a comprehensive perspective.”Rep. Jia Han of the People Power Party also emphasized, “The system cannot outperform reality on the ground,” calling for system design that reflects industrial realities. Rep. Joo-yeon Lee of the Reform Party also expressed concern, stating, “Without concurrent regulatory improvements and creation of an investment-friendly environment, we risk falling behind in global competition.”There was also discussion of international non-proprietary name (INN) prescribing and generic substitution. KPA President Kwon noted that an amendment to the Pharmaceutical Affairs Act, which simplifies post-notification requirements for substitution, has passed the National Assembly and is scheduled to take effect in February. It has been a long-standing aspiration since the introduction of the drug dispensing separation system.”Kwon also cited specific figures regarding INN prescribing, stating, “According to research by the Korea Institute for Pharmaceutical Policy Affairs, INN prescribing could generate total savings of KRW 9 trillion, including drug costs and broader social costs.” She added that public consensus and media attention on INN prescribing are growing.Rep. Young-seok Seo mentioned the legislative progress on generic substitution, noting that “some long-standing goals of public-sector pharmacists, including the generic substitution simplification law and pay raises, have been partially achieved.” However, regarding the broader system, Seo added that “many challenges still remain.”
- Company
- Multiple sclerosis drug Ocrevus lands in Big 5 Hospitals
- by Eo, Yun-Ho Jan 08, 2026 07:31am
- The new multiple sclerosis (MS) drug Ocrevus (ocrelizumab) may now be prescribed at top tertiary hospitals in Korea.According to industry sources, Roche Korea’s relapsing multiple sclerosis (MS) drug Ocrevus (ocrelizumab) has passed drug committee (DC) reviews at major medical institutions nationwide, including Korea’s “Big 5” general hospitals: Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, Seoul St. Mary's Hospital, and Severance Hospital.Since its reimbursement listing in March 2025, Ocrevus has rapidly expanded its prescribing base. With the recent domestic approval of a subcutaneous (SC) formulation, its influence in the MS treatment landscape is expected to continue to grow further.Ocrevus targets CD20-expressing B cells that affect the demyelinating process that causes neurological disorders in MS patients.MS is a chronic disease in which myelin is damaged by an autoimmune inflammatory response. Damage to the myelin sheath causes symptoms such as muscle weakness, fatigue, and vision impairment, and can lead to non-traumatic disability. As of 2022, an estimated 2,674 patients in Korea are known to be suffering from MS, with those in the 20s to 40s age group accounting for more than 62% of the total patient population.Antibody therapies such as Tysabri (natalizumab), Gilenya (fingolimod), and Mabthera (rituximab) have been used for the disease, but there has been a persistent call for additional high-efficacy drugs.Various new drugs have been developed overseas, including Novartis' Kesimpta (ofatumumab) and TG Therapeutics' Briumvi (ublituximab), but Roche's Ocrevus is the only one introduced in Korea.Ocrevus also offers an advantage in dosing convenience. Ocrevus can be administered once every 6 months, which is more convenient than Kesimpta (administered once every month).The approval was based on the Phase III OPERA-I and II studies. The studies evaluated the efficacy and safety of Ocrevus versus Biogen's interferon therapy Plegridy (interferon beta-1a) in patients with relapsing MS.In the trial, Ocrevus reduced the annualized relapse rate (ARR) by nearly half compared to Plegridy. Specifically, in the OPERA I study, the ARR was 0.156 for 96 weeks of Ocrevus versus 0.292 for the control arm, and in OPERA II, the ARR was 0.155 for 96 weeks of Ocrevus versus 0.290 for the control arm.Ocrevus also showed efficacy in the Phase III ORATORIO study in patients with primary progressive MS. In this study, Ocrevus reduced the risk of confirmed disability progression (CDP) by 24% over 12 weeks compared to the control group.Ho Jin Kim, professor of Neurology at the National Cancer Center, said, “In MS, even small differences in the early stages can have huge cumulative consequences. This is why the benefits of early access to highly effective therapies are significant. Such treatments will not only improve patients' quality of life but also help reduce the social and economic burden costs. Ocrevus is highly versatile because it has secured sufficient data not only on efficacy but also on long-term treatment administration.”
