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- 2025-12-19 09:18:16
- Policy
- Budget cut 20% despite increased COVID-19 vaccine uptake
- by Lee, Jeong-Hwan Nov 10, 2025 06:08am
- The Korea Disease Control and Prevention Agency (KDCA) has cut the national immunization program (NIP) budget for COVID-19 vaccines for the 2026-27 season by 20% compared to the previous year, raising societal concern over potential drops in immunity among high-risk groups like the elderly, increased mortality risk, and the possibility of early vaccine stock depletion. Moreover, the KDCA’s 20% cut to the COVID-19 NIP budget was based on the 2023-2024 season's vaccination rate of 42%, failing to reflect the 48% rate from this season (2024-2025 season). This has drawn criticism as an administrative decision that undermines effective epidemic prevention. The National Assembly Budget Office pointed out that both the number of vaccinated individuals and the coverage rate are on the rise, and has urged the KDCA to raise its target vaccination rate and revise the budget accordingly. The Budget Office recommends increasing the budget from the government’s draft of KRW 175.8 billion to KRW 200.8 billion – a KRW 25 billion increase. On the 10th, the National Assembly Health and Welfare Committee will review the KDCA budget, including the COVID-19 vaccine NIP budget, during its plenary session. The COVID-19 vaccine NIP covers high-risk groups - persons aged 65 and older, residents in communal or institutional facilities aged 6 months to 64 years, and immunocompromised individuals – with the aim of securing immunity and preventing severe illness and death. The KDCA set the 2026 NIP budget based on a vaccination rate of 42%. But looking at recent seasons, the number vaccinated was 2.90 million (39.3%) in 2022-23; 4.10 million (41.3%) in 2023-24; and 4.97 million (47.8%) in 2024-25, it was for the 65+ age group, continuing an upward trend. The major issue highlighted by experts and the Budget Office was that, despite rising vaccine uptake, the KDCA’s budget estimate remains anchored to the 42% figure from the 2023-24 season. Given statistics showing the 2024-2025 season vaccination rate approaching 48%, experts and the Office believe that setting the budget based on an incorrect baseline will inevitably lead to early vaccine depletion if the vaccination levels stay the same or increase, making it impossible to achieve the target vaccination rate. The argument is that recognizing the vaccine budget as an investment rather than an expense and rationally increasing the budget for infectious disease response is necessary to prevent potential outbreaks among high-risk groups and increases in mortality rates. In fact, 5.3 million doses of COVID-19 vaccines were secured this year based on last year's vaccination rate. However, increased uptake due to simultaneous COVID-19 and flu vaccination campaigns by health authorities and local governments led to vaccine shortages at some medical institutions just 2 weeks after the National Immunization Program (NIP) began. The NIP is a public health investment to protect citizens' lives. Prioritizing long-term effects over short-term costs will lead to socioeconomic benefits, including reduced healthcare expenses, alleviated burden on the medical system, and maintained national productivity. Furthermore, since the 2023 declaration of endemic status, COVID-19 has continued to mutate repeatedly, with the number of hospitalized patients and mortality rates constantly being reported. According to the KDCA’s infectious disease portal sample surveillance results, the number of COVID-19 hospitalizations last year was approximately 3 times that of influenza hospitalizations. The mortality rate was also higher for COVID-19 hospitalized patients at 5.97%, compared to 3.75% for influenza hospitalized patients. In the National Assembly, lawmakers, including Representative Jin-sook Jeon and Representative Nam-hee Kim of the Democratic Party of Korea, have been scrutinizing the KDCA's unreasonable NIP budget cuts. In response, the NA Budget and Planning Office has proposed the need to increase next year's NIP budget to reflect the rising trend in COVID-19 vaccination numbers and rates. The request is to increase the budget by KRW 25 billion, raising it from the KDCA's budget of KRW 175.8 billion (based on a 42% target vaccination rate) to KRW 200.8 billion (based on a 48% vaccination rate). The Budget and Planning Office analyzed, “Considering the recent trend of increasing COVID-19 NIP vaccinated individuals and vaccination rates across all 3 seasons, there seems to be a need to increase the project budget. Calculating the budget based on raising the target vaccination rate from 42% to 48% (a 6 percentage point increase) results in an estimated KRW 200.8 billion, an additional KRW 25 billion .”
- Policy
- ‘No drugs are benefitting from Korea's dual pricing scheme'
- by Jung, Heung-Jun Nov 10, 2025 06:08am
- Although a separate contract system was introduced for dual pricing of drugs in March this year, following a Ministry of Health and Welfare notice, no drugs are currently subject to the dual drug pricing system, prompting the government to review expansion plans. The NHIS stated it is reviewing with the government on expanding the scope of drugs eligible for the separate contract system. On the 7th, Democratic Party of Korea lawmakers Young-seok Seo and Byeong-hoon So submitted written inquiries during the NHIS’s comprehensive NA audit, seeking clarification on the direction and intent behind expanding the dual pricing policy. The Ministry of Health and Welfare had enacted a new notice titled “Evaluation criteria for drugs requiring assessment based on their impact on healthcare” in March, thereby introducing the separate contract system. Rep Young-seok Seo questioned the drugs currently subject to the system and the operational plan. The NHIS responded, “To be subject to the separate contract system, a drug must satisfy all 3 conditions: being an innovative new drug developed by an innovative pharmaceutical company, being approved under the expedited review system, and having undergone domestic clinical trials. Currently, there are no drugs that meet all the criteria. It added, “We are reviewing with the government and other stakeholders the expansion of drugs subject to the separate contract system to facilitate the early introduction of innovative new drugs for patient treatment access.” Representative Byeong-hoon So inquired about plans for expanding the dual pricing system. He also questioned whether plans exist to ensure fiscal stability when expanding the refund-type contract system. The NHIS stated, “Considering the enhancement of health insurance sustainability and the promotion of an innovative industrial ecosystem, we will consult with the government to improve the drug listing system, including expanding the separate contract system, and establish a balanced roadmap.”
- Company
- GSK seeks reimb for self-injectable form of its asthma drug
- by Eo, Yun-Ho Nov 07, 2025 06:17am
- The self-injectable formulation of the antibody drug ‘Nucala’ is aiming to enter Korea’s insurance reimbursement system. GSK Korea recently filed for insurance reimbursement of its Nucala Autoinjector (mepolizumab), an anti-IL-5 (interleukin-5) antibody for treating eosinophilic diseases. Nucala Autoinjector was approved in Korea last March and was released as a non-reimbursed drug this month after securing a distribution network and supply volume. It remains to be seen whether Nucala, which has established its position in the field of eosinophilic asthma, can successfully secure reimbursement coverage for the new formulation upon its launch and expand its influence in Korea. The new autoinjector formulation is approved not only for severe eosinophilic asthma in adults and adolescents (12 years and older), but also ▲ eosinophilic granulomatosis with polyangiitis (EGPA) in adults, and ▲ hypereosinophilic syndrome (HES) in adults. This medication is a self-administered injection used to treat eosinophilic diseases. It is indicated as add-on maintenance therapy in adolescents and adults aged 12 years and older with severe eosinophilic asthma (SEA), as add-on maintenance therapy in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), and as add-on maintenance therapy in adult patients with hypereosinophilic syndrome (excluding HES, FIP1L1-PDGFRα positive patients). The autoinjector formulation enables patients to self-administer injections conveniently at home. This is evidenced by a self-injection success rate exceeding 96%, high patient preference, and ease of use. Meanwhile, Nucala has been enhancing its competitiveness by securing an indication for chronic obstructive pulmonary disease (COPD). The drug obtained additional approval from the U.S. FDA in May as an “add-on maintenance therapy for adult patients with COPD with an eosinophilic phenotype.” This approval was based on the results of the Phase III MATINEE and METREX studies. In these studies, among a broad spectrum of COPD patients with an eosinophilic phenotype, the Nucala treatment group showed a significantly lower annual rate of moderate-to-severe exacerbations compared to the placebo group.
- Company
- "Rise of regenerative aesthetics focused on natural beauty"
- by Hwang, byoung woo Nov 07, 2025 06:17am
- As the use of medical aesthetics treatments expands, the field is moving away from excessive volume correction toward a focus on natural balance and improved skin quality. As the proportion of surgical procedures decreases, minimally invasive procedures are expanding, and a strategy focused on maintaining long-term safety and efficacy is becoming more critical. DailyPharm met with Dr. Jonathan Kadouch, a dermatologist in the Netherlands, to discuss trends in global medical aesthetics and strategies for safety management in injectable procedures. "From overcorrection to balance...natural aesthetics is trending" Dr. Kadouch explained that the most significant recent change in the field of medical aesthetics is the 'transition from overcorrection to natural harmony.' Dr. Jonathan Kadouch (dermatologist in the Netherlands)"Over the past 20 years, surgical procedures have decreased, and minimally invasive injectable procedures have become the mainstream," he said. "The focus is shifting from simply adding volume to restoring balance, considering the face's structure and tissue changes." Notably, strategies to enhance the skin's inherent quality and its regeneration process are currently gaining attention. Dr. Kadouch said, "Regenerative aesthetics is not just about creating volume, but about creating an environment where tissues can heal themselves," and added, "As interest in regenerative medicine, such as quality improvement, is growing, the medical aesthetics trend is evolving toward prioritizing procedure safety." Dr. Kadouch also emphasized, "In the past, artificially correcting many areas of the face was popular, but now, both patients and medical professionals prioritize natural and long-term sustainable results." "HA and CaHA differ in mechanism and complication management" The major injectable agents are Hyaluronic Acid (HA) fillers and Calcium Hydroxylapatite (CaHA). Although they appear similar, the two agents differ in their mechanisms of action and approaches to managing complications. First, HA fillers are characterized by their degradability with hyaluronidase. This allows for immediate management should side effects occur or if aesthetic adjustments are needed during the procedure. In contrast, CaHA is a microparticle that induces collagen and elastin production as it gradually degrades in the body. Dr. Kadouch distinguished them, explaining, "HA is a natural component of the human body found in joints, eyes, and skin, and has established itself in the medical aesthetics market for improving volume and wrinkles." He added, "CaHA is a biostimulator that promotes tissue regeneration, where anatomical understanding and the precision of the injection layer determine the treatment outcome." Given the high interest in minimally invasive procedures and safety, the approach to managing complications differs between HA and CaHA. Dr. Kadouch explained, "The biggest advantage of HA filler is its reversibility, meaning most issues can be managed by dissolving the filler using hyaluronidase." He noted, "CaHA lacks a dissolving enzyme, requiring an algorithm-based approach to reduce particle concentration or induce tissue diffusion." Dr. Kadouch also mentioned, "The lack of a specific dissolving agent can be a burden for practitioners with limited clinical experience with CaHA. However, as CaHA is increasingly used for regenerative purposes rather than volume correction, the risks of complications and side effects have significantly reduced compared to the past." "Evidence-based product selection and patient expectation management are key" Notably, Dr. Kadouch emphasized that while complications and adverse reactions from filler procedures are often multifactorial, selecting products based on scientific evidence is crucial for ensuring procedure safety. "The more clinical papers and research results a product has accumulated to prove its safety and efficacy, the higher the confidence a practitioner can have in selecting that product," Dr. Kadouch said. "Therefore, rationale decision-making based on objective data and literature is the starting point for safe procedures." Dr. Kadouch said, "Some biostimulator agents have long-proven safety and efficacy," and added, "In contrast, some rapidly expanding new products lack sufficient data accumulation, necessitating a cautious approach." He also explained that with the increase in patients requesting specific procedures seen on social media, the consultation process is important for managing patient expectations. Dr. Kadouch stated, "As information dissemination through social media accelerates, the speed at which specific procedures or products become trends has also become very fast. Combined with new products and marketing, physicians in the medical aesthetics field face greater challenges than before." However, Dr. Kadouch believes that medical professionals must uphold their medical convictions and ethical standards while still meeting patient expectations amid this changing trend. Dr. Kadouch emphasized, "If medical professionals present scientific evidence and logical reasons, many patients understand and prioritize safety in their decisions," and stressed, "Adequately guiding patients on the limitations of expectations and the criteria for safe product selection is essential not only for medical ethics but also for providing trust-based treatment." Finally, Dr. Kadouch projected that the future of the medical aesthetics field will center on improving skin quality, long-term maintenance treatment, and combined-procedure strategies. Dr. Kadouch said, "Across the industry, invasive procedures are being minimized, and the shift toward minimally invasive or non-invasive procedures is clear and expected to continue," and added, "Combining the advantages of different procedures to improve overall skin quality is expected to become the core trend in the aesthetics field."
- Policy
- The application for selective reimb of new drugs is stalled
- by Jung, Heung-Jun Nov 07, 2025 06:17am
- Roche Korea's 'Perjeta (pertuzumab),' a breast cancer treatment, was not on the recent Cancer Disease Review Committee (CDRC) agenda, despite expectations, raising questions about the background of its exclusion. One analysis suggests that the government's policy shift toward strengthening access to rare and severe disease treatments may have contributed. The view is that the Health Insurance Review & Assessment Service (HIRA) must exercise caution in applying selective reimbursement to drugs, as it aligns with impending changes to government policy. According to industry sources on the 5th, discussions on establishing reimbursement criteria for Roche Korea's HER2-positive breast cancer treatment, Perjeta, were not considered in the recent CDRC meeting, reportedly due to an application for selective reimbursement. The CDRC meeting results determined the reimbursement status for 6 products from 5 companies. Perjeta, which was expected to be on the agenda, was not included in the list of drugs discussed. Perjeta is currently applicable for selective reimbursement (with a 30% patient co-payment) for neoadjuvant (pre-operative) therapy for early breast cancer. It is reported that the company has now also applied for selective reimbursement for the post-operative therapy indication. Selective reimbursement was first implemented in 2018 under the previous Moon Jae-in administration as part of its healthcare policy to provide coverage for non-reimbursed treatments. At the time, the government planned a 3-year timeline for anti-cancer drugs and a 5-year timeline for general drugs under the Moon Jae-in Care policy, aiming to reduce patient burden for drugs with high social demand but difficult full reimbursement. With this policy, some new drugs, including anti-cancer agents, received selective reimbursement, but attempts to enter this category have been rare since. Most recent changes involve adjustments to the patient co-payment ratio for drugs already under selective reimbursement. Looking at the current list of reimbursed drugs, 123 items are subject to selective reimbursement. Excluding 97 choline alfoscerate products, which were transitioned to selective reimbursement (with an 80% co-payment) last September, the number of new drugs granted selective reimbursement is small. No new drugs have been granted selective reimbursement this year. The Lee Jae Myung administration is currently pushing a plan to expand access to treatment for rare and severe diseases. Although specific implementation plans have not been formalized, a systemic reform is anticipated. Consequently, analysis suggests that the implementation of selective reimbursement for new drugs, which was part of the previous administration's 3- to 5-year plan, is being delayed to align with the latest, changing policy direction.
- Company
- 31 Chinese, 2 Korean firms rank among the global Top 100
- by Kim, Jin-Gu Nov 07, 2025 06:16am
- Two Korean companies made it into the Top 100 global pharmaceutical and biotech firms by revenue. Samsung Biologics and Celltrion ranked 64th and 87th, respectively. By nationality, Chinese and Hong Kong-based companies led with 31 firms, followed by the US (23), Japan (12), and India (6). According to data released on the 6th by BullFincher, a global listed-company analytics platform, Johnson & Johnson led the global rankings among global pharmaceutical and biotech companies. This result comes from aggregating the trailing twelve months (TTM) sales of all global listed pharmaceutical and biotech companies, without distinguishing between pharmaceutical and biotech firms. Johnson & Johnson's revenue from Q4 last year to Q3 this year reached USD 92.15 billion (approximately KRW 1,133 trillion). This figure includes performance from both its pharmaceuticals and medical device divisions. Following Johnson & Johnson, MSD (US Merck), Pfizer, AbbVie, Eli Lilly, AstraZeneca, Novartis, Bayer, Sanofi, and Novo Nordisk rounded out the top 10 companies. All five top spots in the rank were held by U.S. companies. By market capitalization, however, Eli Lilly remains the global leader, valued at USD 805.3 billion, roughly 1.8 times higher than the runner-up Johnson & Johnson (USD 448.8 billion). Other Top 10 market-cap players include AbbVie, AstraZeneca, Novartis, Novo Nordisk, MSD, Amgen, Gilead Sciences, and Pfizer. Among the top 100 pharmaceutical and biotech companies by revenue, Chinese and Hong Kong-based companies are the most numerous at 31. This is followed by the United States with 23, Japan with 12, India with 6, the United Kingdom with 4, and Germany, Denmark, Switzerland, and France each with 3. Among Korean companies, Samsung Biologics and Celltrion made the Top 100 list. Samsung Biologics' revenue for the past year (Q4 last year to Q3 this year) was KRW 5.5048 trillion, ranking 64th in revenue. This is similar to the level of Germany's BioNTech SE, known for developing mRNA vaccines. Celltrion ranked 87th. Celltrion's revenue over the past year was KRW 3.896 trillion. This is comparable in scale to China's Innovent Biologics and India's Lupin. The presence of Korean companies was more prominent in terms of market capitalization. Five Korean firms are included in the Top 100 global pharmaceutical and biotech companies by market cap: Samsung Biologics (25th), Celltrion (30th), Alteogen (32nd), SK Biopharm (90th), and Yuhan Corporation (99th).
- Opinion
- [Reporter’s View] K-obesity drugs need to innovate
- by Choi, Da-eun Nov 07, 2025 06:16am
- The global obesity treatment market is expected to continue its rapid growth. Novartis ‘Wegovy’ and Eli Lilly's ‘Mounjaro’ are both now entering their third year as industry game-changers. Both drugs are glucagon-like peptide-1 (GLP-1) receptor agonist injections that suppress appetite and reduce weight, popularizing the recognition that obesity is not merely a cosmetic issue but a ‘disease’. In Korea, momentum is building, heralding the introduction of homegrown obesity drugs. Major pharmaceutical companies like Hanmi Pharmaceutical, Daewoong Pharmaceutical, and HK Inno.N have successively unveiled new candidates and initiated clinical trials. Their ambition is to reduce dependence on original drugs and secure market leadership through technological self-reliance. Yet, challenges remain formidable. The global leaders Wegovy and Mounjaro have already secured large-scale, long-term data after receiving FDA and EMA approvals through trials involving thousands of patients. Furthermore, the market's focus is shifting from injectables to oral tablets. Novo Nordisk's high-dose oral semaglutide and Eli Lilly's oral low-molecular-weight GLP-1 agonist ‘Orforglipron’ have both achieved positive results in Phase III clinical trials. Novo Nordisk has submitted its new drug application to the U.S. Food and Drug Administration (FDA), which is expected to make a decision on approval within the fourth quarter. If approved, commercialization is expected within the next year. Eli Lilly's Orforglipron has been designated for FDA Fast Track review and is currently under review. The company plans to apply for approval as an obesity treatment within this year and as a type 2 diabetes treatment next year. With the dawn of this ‘oral obesity drug’ era, the market landscape is expected to shift, driven by the convenience of administration and high treatment adherence rates offered by the oral formulations. In contrast, domestic pharmaceutical companies are still just in the entry stage. Major firms like Hanmi Pharma, Dong-A ST, Daewoong Pharmaceutical, and HK Inno.N have revealed their candidates and entered clinical trials, but most are still in the injectable formulation phase. Compared to global companies already advancing oral formulations to commercialization, the development speed gap is clear. Disparities exist not only in technological capability but also in clinical experience, data scale, and regulatory strategies. Safety and misuse are also growing concerns. While GLP-1 drugs deliver dramatic appetite suppression, they’ve also been linked to gastrointestinal disorders, muscle loss, and psychiatric side effects. Misuse of “weight-loss injections” has already become a social issue in both Western and Korean markets. If domestic pharmaceutical companies aim to enter the market with drugs using similar mechanisms, differentiating their safety profile is as essential as efficacy. Economics present another hurdle. Without reimbursement, the monthly cost of Wegovy or Mounjaro ranges from KRW 200,000 to KRW 500,000, depending on dosage. For a homegrown drug to succeed, it must compete with big pharma treatments through low production costs and reasonable pricing to build market dominance. Still, there are signs of promise. Hanmi Pharmaceutical is advancing multiple novel candidates, including the triple-action obesity treatment ‘HM15275’ that minimizes muscle loss, the muscle-building obesity treatment ‘HM17321’, and the oral GLP-1 receptor agonist obesity treatment ‘HM101460.’ Companies like Dong-A ST, Progen, and D&D Pharmatech are developing next-generation GLP-1 drugs that apply dual-action mechanisms. For domestically developed drugs to truly establish themselves as ‘K-Obesity drugs,’ four elements must align: technological capability, data, ethical standards, and speed. ‘Homegrown’ alone will not persuade patients or markets. However, if the focus is on ‘innovation’ rather than mere replication, there is ample potential for K-Obesity drugs’ success in the global market.
- Company
- Samsung Biologics spins off Samsung Epis Holdings
- by Cha, Jihyun Nov 06, 2025 06:34am
- Samsung Biologics spun off its investment and subsidiary management business unit to establish Samsung Epis Holdings as a dedicated bio investment holding company The company announced on the 3rd that the holding company was officially established following a board resolution. Samsung Bioepis Holdings will establish separate subsidiaries to pursue bio-technology platform development projects, while retaining Samsung Bioepis—a company focused on developing and commercializing biosimilars (generic versions of biopharmaceuticals)—as a wholly-owned subsidiary. Samsung Epis Holdings plans to maximize enterprise value and shareholder value by establishing tailored strategies for each subsidiary and driving aggressive R&D and investment. First, it intends to further strengthen the biosimilar business capabilities the company has accumulated over the past 13 years. Samsung Bioepis will focus its R&D efforts on securing more than 20 competitive products and pipelines in the biosimilar industry, which is expected to grow steadily alongside rising global demand driven by population aging and chronic disease growth. Since its establishment in 2012, Samsung Bioepis has successfully developed and launched biosimilars for 11 blockbuster biologics. Last year, the company reported record-high sales of KRW 1.5377 trillion and an operating profit of KRW 435.4 billion. Furthermore, Samsung Epis Holdings plans to actively explore promising new businesses based on next-generation technologies by establishing a new subsidiary for future growth. The new subsidiary will pursue innovation and discover new growth engines beyond the biosimilar business by developing next-generation biotech platforms with diverse modalities (treatment approaches). The new subsidiary will adopt a biotech model as its core business structure, focusing on platformizing highly scalable core technologies and developing various new drug candidates to pursue joint development with global pharmaceutical companies. Kyung-ah Kim, the current CEO of Samsung Bioepis, has been appointed as the inaugural CEO of Samsung Epis Holdings and will oversee both the holding entity and its operating subsidiaries. Samsung Epis Holdings will complete legal procedures to establish its new subsidiary by November 14, with re-listing on the Korea Exchange scheduled for November 24. Kim stated, “The launch of Samsung Epis Holdings marks a new leap forward to lead the future global bio industry. We will strengthen synergies across all business divisions to write a unique success story that contributes to a better life for humanity.”
- Company
- GSK reattempts reimb for myelofibrosis drug Omjjara
- by Eo, Yun-Ho Nov 06, 2025 06:33am
- GSK’s myelofibrosis drug Omjjara (momelotinib), which failed reimbursement on its first attempt, is once again seeking insurance reimbursement in Korea. According to industry sources, GSK Korea recently resubmitted its reimbursement application for Omjjara. Despite its recent failure to be presented to the Health Insurance Review and Assessment Service (HIRA) Drug Coverage Evaluation Committee, the company is showing renewed determination. Omjjara passed the Cancer Disease Deliberation Committee review last March, but reimbursement procedures were halted after disagreements arose between GSK and HIRA regarding comparator drug selection for price calculation. Consequently, it remains to be seen whether GSK and the government can reach a consensus this time. Omjjara has a triple mechanism of action that inhibits JAK1 and JAK2 as well as ACVR1 (activin A receptor type 1). In myelofibrosis treatment, JAK1 and JAK2 inhibition helps relieve systemic symptoms and reduce splenomegaly, while ACVR1 inhibition decreases hepcidin expression and thereby alleviates anemia. Anemia management remains one of the major unmet needs in treating myelofibrosis. Transfusion-dependent anemia brings more than just the commonly perceived issue of dizziness - depending on its severity, it can be life-threatening. Phase III trials SIMPLIFY-1 and MOMENTUM demonstrated that Omjjara significantly improved key symptoms such as splenomegaly and reduced transfusion dependence in anemic myelofibrosis patients regardless of prior JAK-inhibitor exposure. In SIMPLIFY-1, which compared Omjjara to ruxolitinib (Jakavi) in JAK-inhibitor-naïve myelofibrosis patients, Omjjara demonstrated non-inferiority to ruxolitinib in the primary endpoint of spleen volume response at week 24. The proportion of transfusion-independent patients was 66.5 % in the Omjjara group versus 49.3 % in the ruxolitinib group, showing a statistically significant reduction in transfusion dependence in the Omjjara arm. Professor Seo-yeon Ahn of Chonnam National University Hwasun Hospital’s Department of Hematology stated, “Existing JAK inhibitors relieve splenomegaly and systemic symptoms but often worsen anemia or increase transfusion needs, leaving an unmet clinical need. Omjjara demonstrated significant clinical value in improving anemia, which is closely tied to prognosis in myelofibrosis patients.”
- Company
- "Fosamax's value in osteoporosis sequential therapy rises"
- by Hwang, byoung woo Nov 06, 2025 06:32am
- As South Korea enters a super-aged society, the importance of long-term management in osteoporosis treatment is being emphasized. During this process, the bisphosphonate class of drugs, demonstrating long-term evidence and sustained efficacy, is once again becoming the key treatment strategy. DailyPharm met with Professor Beom-jun Kim of the Department of Endocrinology and Metabolism at Seoul Asan Hospital, to discuss the changing landscape and future challenges of osteoporosis treatment. "Osteoporosis cases is increasing...prevention before fracture is crucial" Professor Beom-jun Kim of the Department of Endocrinology and Metabolism at Seoul Asan HospitalSouth Korea is one of the world's fastest-aging nations. With the elderly population rapidly increasing, the importance of osteoporosis management and government attention have both grown. In particular, the rise in osteoporosis cases in South Korea is attributed to rapid aging and increased diagnosis rates. Professor Kim explained, "As the elderly population rapidly increased, government attention rose, and this year, osteoporosis screening in general health check-ups was expanded to include women aged 60 and older," and added, "With early prevention and diagnosis underway, the number of patients is also increasing." Osteoporosis is a disease characterized by porous bones. Since it typically presents no specific symptoms before a fracture occurs, it is easily overlooked by both patients and physicians. However, as bone strength naturally declines by about 2% annually with age, the risk of fracture increases. Therefore, continuous management is emphasized, treating osteoporosis as a chronic disease requiring lifelong care, similar to hypertension or hyperlipidemia. He stated, "Spinal and hip fractures not only severely diminish the quality of life due to pain, deformity, and mobility impairment, but hip fractures, in particular, carry a mortality rate of about 20%. Preventing fractures before they occur is particularly important, more so than treating them after one." "Fosamax, a drug with 30 years of evidence...sustained efficacy of oral therapy is gaining attention" To effectively treat osteoporosis, it is essential first to evaluate the patient's fracture risk and prescribe the appropriate medication. According to Professor Kim, various factors are considered, including bone mineral density (BMD), T-score, age, weight, current medications, and family history. Generally, patients with a T-score below -2.5 are diagnosed with osteoporosis and categorized as high-risk for fracture. Bisphosphonate agents, including Fosamax, are globally recommended as the first-line treatment for these patients. The major bisphosphonate, Fosamax (alendronate sodium), celebrates its 30th anniversary this year since its U.S. FDA approval in 1995. It was introduced in Korea in 1998. Professor Kim explained, "The fact that we are still talking about Fosamax after three decades indicates its reliability." He added, "Its preventive effect has been confirmed across various sites, including vertebrae, non-vertebrae, and hip, establishing it as a first-line treatment for high-risk patients in both domestic and international guidelines." He also mentioned the unique advantage of Fosamax as a once-weekly oral drug in the osteoporosis treatment landscape, where injectable drugs are commonly used. Professor Kim pointed out, "According to the Korean Society for Bone and Mineral Research fact sheet, only 73.9% of women and 66.7% of men maintain treatment for a full year after starting medication. For injectables, discontinuing treatment can rapidly increase the risk of multiple vertebral fractures." He added, "In contrast, Fosamax is deposited in the bone and maintains its therapeutic effect for a certain period." He emphasized that this feature, where the fracture-prevention effect persists for a period even after discontinuation, is an advantage in the Korean context, where treatment persistence is often low. "The last in sequential therapy...need to improve access for patients at ultra-high-risk" Professor Kim stressed that the concept of sequential therapy is becoming crucial, as osteoporosis treatment is a long-term strategy rather than a short-term prescription. He said, "Considering the 100-year lifespan, continuously using a single drug is impractical. Therefore, a strategy of sequentially using multiple treatments, similar to hypertension or diabetes, is necessary," And added, "While Fosamax is recommended as a first-line treatment, its advantage as a 'closer' in the context of sequential therapy is gaining attention." Professor Kim also said, "In the 'finishing stage' after reaching the osteoporosis treatment goal, Fosamax has the advantage of maintaining its efficacy in the bone, preventing rapid deterioration of the patient's condition." He added, "Regardless of the initial drug used, treatment must ultimately conclude with a bisphosphonate agent. We believe Fosamax's role in sequential therapy will only grow as new drugs increase." He also evaluated the expansion of reimbursement criteria for osteoporosis treatment last year as a meaningful change. He said, "Previously, patients had to stop treatment coverage if their T-score went above -2.5, even if they wished to continue. Now, the maximum period for continued treatment has been extended up to two years, even at a T-score of -2.0, which is positive for securing treatment continuity." Professor Kim pointed out the institutional need to lift restrictions on the treatment sequence for ultra-high-risk patients and advised against avoiding treatment due to concerns about adverse reactions. Professor Kim said, "Globally, the recommended strategy is first to use bone formation promoters (anabolic agents) followed by anti-resorptive agents for maintenance. However, due to current domestic reimbursement criteria, we must apply this in reverse," and suggested, "The treatment sequence needs to be improved, at least for the ultra-high-risk group." Finally, Professor Kim said, "Although fear of adverse reactions is one reason for hesitation, concerns like 'jawbone necrosis' are actually very rare," and added, "The incidence in South Korea is around 4 per 10,000 people (0.04%), while the risk of fracture is a thousand times higher. Avoiding treatment due to a rare risk is like not wearing a seatbelt."
