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- 2025-12-18 22:53:36
- Policy
- GLP-1 drug Ozempic passes reimbursement review
- by Jung, Heung-Jun Oct 10, 2025 06:05am
- Novo Nordisk’s GLP-1 receptor agonist Ozempic (semaglutide) has passed review by the Health Insurance Review and Assessment Service (HIRA)’s Drug Reimbursement Evaluation Committee, which acknowledged the drug as adequate for reimbursement. Ozempic contains the same active ingredient as the obesity drug Wegovy, but is indicated for diabetes. Meanwhile, the reimbursement scope for Janssen Korea’s prostate cancer drug Erleada (apalutamide) will be expanded. In addition to the existing indication of “metastatic hormone-sensitive prostate cancer (mHSPC),” the new coverage will include treatment for “high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).” On October 2, HIRA held its 10th Drug Reimbursement Evaluation Committee meeting of 2025 to review applications for new drug reimbursement and expanded indications for drugs under risk-sharing agreements. Three drugs - Novo Nordisk’s Ozempic pre-filled pen (semaglutide 2 mg/1.5 mL, 4 mg/3 mL); Shinpoong Pharm’s Hyalflex Inj (hexamethylenediamine dihydrochloride bridged sodium hyaluronic acid gel) for knee osteoarthritis; and Mitsubishi Tanabe Pharma Korea’s Uplizna Inj (inebilizumab) for neuromyelitis optica spectrum disorder (NMOSD) – were reviewed. Ozempic was recognized as adequate for reimbursement “as an adjunct to diet and exercise for adults with type 2 diabetes inadequately controlled by existing therapies (in combination with other antidiabetic agents).” This marks the second time the drug has cleared reimbursement evaluation since 2023. While the first approval included a condition to accept a price below the assessed value, this latest decision carries no such condition. Novo Nordisk reportedly made substantial efforts by submitting supplementary data to HIRA for reimbursement and will now proceed to price negotiations with the National Health Insurance Service (NHIS). Uplizna was recognized as adequate for conditional reimbursement – allowed reimbursement when the company accepts a price below the assessed value—for treating “adult patients positive for anti-aquaporin-4 (AQP4) antibodies with neuromyelitis optica spectrum disorder.” The final listing will follow after the company completes price negotiations with the NHIS. Erleada’s reimbursement will expand to include “high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).” The drug has been reimbursed since April 2023 for “metastatic hormone-sensitive prostate cancer (mHSPC).”
- Company
- Boryung acquires global rights to Taxotere for KRW 288B
- by Chon, Seung-Hyun Oct 02, 2025 06:13am
- Boryung acquired global rights to Sanofi's anticancer drug ‘Taxotere’ for up to KRW 287.8 billion. This investment, approaching KRW 300 billion, secures a revenue stream of approximately KRW 100 billion in annual sales. Boryung announced on the 30th that it has signed a global licensing agreement with Sanofi for the global business of the cytotoxic anticancer drug ‘Taxotere’ (docetaxel), including domestic and international rights, distribution rights, licensing rights, production rights, and trademark rights. The deal is valued at up to EUR 175 million (KRW 287.8 billion). Of this, EUR 161 million (KRW 264.8 billion) will be paid at closing, while the remaining EUR 14 million (KRW 23 billion) will be contingent on achieving certain contractual milestones. Through this acquisition, Boryung will take over the comprehensive business operations of Taxotere in 19 countries, including Korea, China, Germany, and Spain, as well as in Latin America and the Middle East, subject to approval by local regulatory authorities. Once regulatory procedures are completed, Boryung plans to manufacture Taxotere at its Yesan Campus and directly distribute and market the drug in global markets. Docetaxel is listed on the WHO Model List of Essential Medicines, and Taxotere is the original brand product of docetaxel. First approved by the U.S. FDA in 1995, Taxotere has been widely used for the treatment of various solid tumors, including breast cancer, prostate cancer, gastric cancer, and head & neck cancers. According to Sanofi, the product generated global sales of EUR 70 million (KRW 115.4 billion) last year. Even today, the clinical utility of Taxotere continues to expand, particularly in combination therapies, reinforcing its role as a key component in global cancer treatment. A Boryung representative explained, “Although the paradigm in oncology is shifting toward targeted and immuno-oncology therapies, cytotoxic agents remain a fundamental backbone of cancer treatment.” Boryung has previously taken over the domestic operations of global original oncology drugs such as Gemzar (2021) and Alimta (2023), successfully transitioning them to in-house production and ensuring stable supply. Boryung aims to advance as a global pharmaceutical company in the field of cytotoxic anticancer drugs through the acquisition of the Taxotere business. A Boryung official emphasized, “In the actual global market, repeated stockouts and supply disruptions of cytotoxic anticancer drugs are impacting patient treatment. Through this acquisition of the Taxotere global business, we plan to expand our differentiated portfolio in the cytotoxic anticancer drug field by stably establishing the global supply chain for these essential medicines, whose importance has grown.” Jeong-Gyun Kim, CEO of Boryung, said, “Boryung has gone beyond simple product acquisitions, internalizing manufacturing and formulation improvements to secure sustainable competitiveness. The Taxotere global business acquisition marks not only our third anticancer drug takeover after Gemzar and Alimta, but also the first time we have acquired global rights to an original medicine, paving the way for full-scale overseas expansion.” Kim added, “We will advance Taxotere's therapeutic value by expanding beyond simple technology transfer into comprehensive R&D, including follow-up formulation development, combination therapy strategies, and research into new indications. Through this, we aim to strengthen our differentiated portfolio in the cytotoxic oncology field, directly manufacture and distribute original anticancer medicines on the global stage, and reinforce our future growth engines.”.
- Company
- Severe asthma drug 'Fasenra' enters 'Big 5' gen hospitals
- by Eo, Yun-Ho Oct 02, 2025 06:11am
- Product photo of Fasenra 'Fasenra,' a treatment for severe asthma, is now available by prescription at tertiary general hospitals. According to industry sources, AstraZeneca Korea's Fasenra (benralizumab) passed the drug committees (DC) of 'Big 5' general hospitals, including Samsung Medical Center (Seoul), Seoul National University Hospital, Seoul Asan Medical Center, Seoul St. Mary's Hospital, and Sinchon Severance Hospital. Fasenra was included in the insurance reimbursement list in July of last year. The drug can be reimbursed when treating patients with severe eosinophilic asthma who are inadequately controlled despite treatment with high-dose inhaled corticosteroid-long-acting beta-agonist (ICS/LABA) and long-acting muscarinic antagonist (LAMA). Specifically, the following criteria should be met: ▲Within the year before starting treatment, the eosinophil count in the blood was 300 cells/㎕ or higher, and within the first year of treatment, systemic oral corticosteroids (OCS) were required for acute exacerbations four or more times, or within 6 months before starting therapy, systemic oral corticosteroids were continuously administered, or ▲The eosinophil count in the blood was 400 cells/㎕ or higher within the year before starting treatment. Systemic corticosteroids were required for acute exacerbations three or more times within the first year of treatment. Severe eosinophilic asthma accounts for approximately 84% of severe asthma cases. It involves frequent exacerbations and may lead to reduced quality of life despite treatment with high-dose inhaled corticosteroids and other conventional therapies. In particular, when symptoms are not controlled, even with asthma controllers, oral steroids may be necessary. However, long-term use of these medications is associated with systemic side effects such as osteoporosis, hypertension, and diabetes. Therefore, biological agents are recommended to reduce the dosage of these treatments. Fasenra is a targeted biologic agent that binds directly to interleukin-5 receptor alpha (IL-5Rα) expressed on eosinophils' surface, inducing cell apoptosis. It has been demonstrated to reduce blood eosinophil counts rapidly within one day of administration. Meanwhile, in the results from the global Phase 3 SIROCCO clinical trial, enrolling 1,205 severe eosinophilic asthma patients worldwide, including those in Korea, Fasenra administered at 8-week intervals showed a 51% reduction in annual asthma exacerbation rates compared to placebo after 48 weeks of treatment. In the CALIMA study, Fasenra treatment also resulted in a 28% reduction in annual asthma exacerbation rates compared to placebo.
- Company
- CKD to exclusively sell Bayer’s heart failure drug Verquvo
- by Chon, Seung-Hyun Oct 02, 2025 06:11am
- Chong Kun Dang announced on the 1st that it has signed an exclusive sales agreement with Bayer Korea for the chronic heart failure treatment ‘Verquvo’. Under the agreement, Chong Kun Dang will handle the exclusive distribution, sales, and marketing of Verquvo at domestic hospitals and clinics starting this month. Verquvo is a treatment for symptomatic chronic heart failure in patients with a left ventricular ejection fraction (LVEF) of less than 45%. It is the world’s first soluble guanylate cyclase (sGC) stimulator approved for chronic heart failure. The drug directly stimulates the nitric oxide–sGC–cGMP pathway, demonstrating efficacy in improving vascular function and enhancing cardiac structure and function. In global clinical trials, Verquvo was shown to reduce the risk of cardiovascular death and hospitalization due to heart failure in high-risk chronic heart failure patients who had experienced worsening of symptoms despite standard therapy. It is evaluated as presenting a new treatment paradigm for high-risk patient groups, acting through a mechanism distinct from existing neurohormone blockade-centered therapies. Chong Kun Dang and Bayer Korea have been long-standing partners. Since 2005, they have co-promoted antibiotics such as Cifrobay and Avelox, and since last year, they have co-marketed Kerendia, a treatment for chronic kidney disease associated with type 2 diabetes. In February 2024, Chong Kun Dang also began exclusive sales of Bayer’s progressive hepatocellular carcinoma treatments Nexavar and Stivarga in Korea, further strengthening their partnership. Young-Joo Kim, President of Chong Kun Dang Pharma, said, “Chong Kun Dang has been leading the cardiovascular disease treatment market based on its extensive experience and expertise in the field. With the exclusive sales of Verquvo, we will be able to establish a differentiated portfolio in the field of chronic heart failure treatment and provide patients with broader therapeutic options.” JinA Lee, President/CEO of Bayer Korea, said, “Since Verquvo was reimbursed under the national health insurance in September 2023, it has become a cornerstone treatment for patients experiencing worsening heart failure symptoms. Through our collaboration with Chong Kun Dang, we hope more Korean patients with chronic heart failure can benefit from Verquvo’s proven clinical value.”
- Company
- Servier Korea appoints Olivier Russo as new General Manager
- by Son, Hyung Min Oct 02, 2025 06:11am
- Olivier Russo, new General Manage of Servier Korea Servier Korea announced that it has appointed Olivier Russo as its new General Manager, effective October 1. Olivier Russo, the new GM, is a pharmacist and R&D expert who earned his PhD in Organic Chemistry and Medicinal Chemistry from the Université Paris-Saclay in France. Since joining the Servier Group in 2006, he has demonstrated leadership across core R&D functions throughout the entire drug lifecycle—from early-stage discovery of novel drug candidates to technology development, industrialization, and post-approval stages. Since 2022, Russo has served as Global Head of CMC, where he led company-wide strategy and operations. He successfully supported the initiation of clinical trials and regulatory approvals for key pipeline candidates in oncology, neuroscience, and immunology/inflammatory diseases, as well as the full lifecycle management program for cardiovascular and metabolic disease treatments. The new GM said, “Korea not only holds a strong presence in key areas for Servier, such as cardiovascular and metabolic diseases, but is also emerging as a new leader in targeted cancer therapy. As part of Servier's Asia-Pacific R&D hub, Korea is also a strategic center for strengthening the clinical development foundation in the region.” He added, “We will strive to combine the strengths of the Korean market with Servier's global expertise to deliver greater value to patients worldwide, while driving sustained innovation.” Servier is an independent global pharmaceutical group managed by a non-profit foundation. Headquartered in France, it has a strong global presence in over 140 countries. Driven by its mission to advance treatments that meet patient needs, it focuses approximately 70% of its R&D budget on oncology, providing innovative medicines primarily in oncology and cardiovascular and metabolic diseases.
- Product
- DP·gov't "INN prescriptions for supply shortage drugs"
- by Kim JiEun Oct 02, 2025 06:11am
- A public forum was held in the National Assembly to discuss the International Nonproprietary Name (INN) prescriptions. Civic groups, pharmacists, and healthcare experts have unanimously agreed that the government should consider implementing the system if it enhances patient choice and reduces national spending. The policy debate, titled 'Introduction of a Korean Model of International Nonproprietary Name (INN) prescriptions to Expand the Public's Choice of Dispensed Medicines,' took place at the National Assembly on September 30. The event was hosted by Democratic Party of Korea Representatives In-soon Nam, Young-seok Seo, Yoon Kim, and Jong-tae Jang, as well as Cho Kuk Innovation Party Representative Sun-min Kim. The Korean Pharmaceutical Association and the Research Institute for Pharmaceutical Policy also hosted it. The panelists agreed that the INN prescriptions should not be viewed merely as a dispute over vested interests between doctors and pharmacists. The priority, they stressed, should be identifying the system that best benefits patients, who are insurance subscribers, by increasing their right to choose medication, and the government should design the system accordingly. The governing parties and the government, who are the proponents of the system's introduction, stated that they agree on the necessity of the system for drugs with unstable supply and are currently pursuing it. However, they presented the prerequisite that public consensus on the need for the system must be formed first. Taek-woo Kim, President of the Korean Medical Association, conducted a solo demonstration directly outside the National Assembly gate to protest the introduction of INN prescriptions At the same time, the debate was being held inside the National Assembly, Taek-woo Kim, President of the Korean Medical Association, conducted a solo demonstration directly outside the National Assembly gate to protest the introduction of INN prescriptions, drawing attention. "Will Enhance Patient Choice and Fiscal Savings…The Best System Helps Patients" Sung-min Park, an associate professor at Seoul National UniversityIt was emphasized at the forum that the need to discuss INN prescriptions from the perspective of patient safety and the expansion of patient choice. Sung-min Park, an associate professor at Seoul National University's Graduate School of Public Health, said, "Brand-based drug labeling increases the risk of confusion and errors during prescribing, dispensing, and administration." He added, "There is a risk of prescribing and dispensing mistakes due to confusion with similar names. Patients also face a higher risk of mistakenly taking the wrong drug." Professor Park said, "When patients with multiple illnesses receive prescriptions from various medical institutions, there is a high possibility of being prescribed the same drug ingredient redundantly," and added, "If patients are unaware of the ingredients, they are more likely to overdose, and discarded unused drugs lead to unnecessary expenditure of National Health Insurance funds." Sun-Young Oh, Director of Policy at the Korean Health and Medical WorkersSun-Young Oh, Director of Policy at the Korean Health and Medical Workers' Union, emphasized, "The expected effect of introducing INN prescriptions is granting patients, as subscribers to the National Health Insurance, the right to choose their medication." She asserted, "Patients lack specialized knowledge about medicine compared to doctors and pharmacists. Creating an environment where patients can make choices must be prioritized. Furthermore, the system must be premised on the therapeutic equivalence of generics so that patients are not anxious about their choices." Oh also said, "Encouraging patient participation in and choice over the medication they take is the desirable direction for this system," adding, "It also has the advantage of reducing dependence on brand names, which is currently very high." "Not a dispute over interests between doctors and pharmacists… Key to Completing Separation of Prescribing and Dispensing" Kwang-min Lee, Vice President of the Korean Pharmaceutical Association, argued that the current brand-name prescribing practice prevents the fundamental intent of the Separation of Prescribing and Dispensing System from being realized. Kwang-min Lee, Vice President of the Korean Pharmaceutical AssociationLee stated that despite the government implementing policies such as deleting the prescription fee item from doctors' service fees and using a market-based actual transaction price reimbursement system for reimbursable drugs, these policies are rendered ineffective by brand-name prescribing. Furthermore, Lee also pointed out that brand-name prescribing directly influences prescribing behavior and healthcare utilization, citing the tendency for self-injectable drugs, such as obesity injections, to be dispensed directly by hospitals. Lee directly criticized the link between brand-name prescribing and illegal business practices by pharmaceutical companies, wholesalers, and CSOs, arguing that it leads to the misuse and abuse of medications. Lee said, "If INN prescriptions become implemented, patients will be able to conveniently receive dispensing services at pharmacies near their homes or workplaces, not just those near medical institutions." He added, "Even patients using multiple institutions for multiple illnesses can receive unified dispensing and medication guidance services from their regular pharmacy, rather than relying on pharmacies near each institution. This will also have the effect of reducing unnecessary drug use." Nam Eun-kyung Lee added, "In Korea, where alarms are sounding over the worsening financial health of the National Health Insurance, a system is needed to promote the use of cost-effective medicines during the prescribing and dispensing stages," and emphasized, "Generic prescribing should not be dismissed as merely a dispute over pharmacists' and doctors' interests; it must be designed with the public at the center to ensure the stability and sustainability of the domestic public health finances." A criticism was also raised that the government needs to take a clear stance on the doctors' argument against INN prescriptions that "even drugs with the same ingredients may differ in efficacy depending on the formulation (release mechanism, dosage form, excipients, etc.)." Nam Eun-kyung pointed out, "The government must clearly draw the line on the controversy over whether generics are different drugs or identical ones. By not formalizing its position, the government is causing unnecessary social conflict." Nam added, "Provided that safety and efficacy are not compromised, the public will agree to a policy that can save NHI funds. I understand that both the Democratic Party and the government are willing to put INN prescriptions on the public agenda. I hope a forum for public discussion involving doctors, pharmacists, and the public can be arranged." "INN prescriptions limited to supply shortage drugs still under discussion"…what do the governing party and government plan? What are the opinions of the National Assembly and the government regarding the highly debated INN prescriptions? Rep. Won-joon Cho, Senior Expert Member for Health and Welfare at the Democratic Party of KoreaThe ruling Democratic Party of Korea and the administrative ministry, the Ministry of Health and Welfare, both agreed on the necessity of introducing the system limited to supply shortage drugs. However, they drew a clear line, stating that widespread adoption of the system would require prior public consensus. Rep. Won-joon Cho, Senior Expert Member for Health and Welfare at the Democratic Party of Korea, explained, "The Tylenol shortage was one of the three major crises after COVID-19. Even in the National Assembly, there was an internal discussion about the need for INN prescriptions for a certain period, given the special circumstances of the pandemic, but it was not pursued," and added, "At that time, the burden of opposition from the medical community could not be overcome. It is from this perspective that a limited INN prescriptions was included in the Democratic Party's last presidential election pledge." Rep. Cho said, "Bills related to INN prescriptions are being introduced, and the National Assembly has plans to discuss institutional improvements and legal amendments." He added, "Various policy measures are being proposed to resolve drug supply instability in addition to the limited introduction of INN prescriptions. All these policy measures must be mobilized to resolve the recurring problem of drug supply instability as much as possible." Jun-hyuk Kang, Director of the Pharmaceutical Policy Division at the Ministry of Health and WelfareFurthermore, Cho added, "However, for the system to be introduced, it must be clearly explained how it will help the public." He concluded, "I believe the system's introduction can gain momentum when public consensus on its rationality and sustainability is formed." Jun-hyuk Kang, Director of the Pharmaceutical Policy Division at the Ministry of Health and Welfare, said, "The government is viewing INN prescriptions from the perspective of the public's drug accessibility." He added, "While Korea has many pharmacies per capita, some administrative districts lack pharmacies, and the issue of drug accessibility has been raised due to unstable drug supply. INN prescriptions is one of the alternatives being discussed to resolve this." Kang said, "It is undesirable that this issue is being highlighted as a conflict between doctors and pharmacists," and added, "Doctors, pharmacists, and the public must discuss this to find a common ground." He concluded, "The government is preparing measures to simplify alternative dispensing and introduce INN prescriptions limited to supply shortage drugs. It seems necessary to conduct specific research on how to introduce INN prescriptions for supply shortage drugs. We understand that foreign countries encourage this through various methods, not necessarily mandating it. We also intend to review these aspects.
- Company
- Will Uplizna be reimbursed this time?
- by Eo, Yun-Ho Oct 01, 2025 06:11am
- Discussions have resumed regarding the inclusion of the twice-yearly administered new drug ‘Uplizna’ for neuromyelitis optica spectrum disorder (NMOSD) in the national health insurance reimbursement list, which had previously been rejected. According to industry sources, Mitsubishi Tanabe Pharma Korea has resubmitted an application for reimbursement of Uplizna (inebilizumab), a treatment for adult patients with AQP4 antibody–positive NMOSD, which is currently under review by the Health Insurance Review and Assessment Service. The drug’s listing process was suspended in October last year during price negotiations with the National Health Insurance Service (NHIS) due to supply issues. At the time, Uplizna accepted the evaluation price set by HIRA’s Drug Reimbursement Review Committee and entered into negotiations. However, no conclusion was reached within the 60-day negotiation period. NHIS attempted to extend negotiations, but the manufacturer was unable to secure a domestic supply, preventing further talks. It remains to be seen whether Uplizna, as a new treatment option for NMOSD, will succeed in being listed this time. NMOSD is caused when disease-specific AQP4 autoantibodies, produced by B cells, bind to AQP4 antigens on astrocytes in the central nervous system, triggering immune responses that lead to neural damage. Uplizna is a novel CD19-targeted humanized monoclonal antibody that selectively binds to the CD19 antigen on B cells, depleting those that produce AQP4 antibodies and thereby preventing disease relapse. The safety and efficacy of Uplizna were demonstrated in the N-MOmentum trial, a monotherapy study involving 230 patients without concomitant immunosuppressants. Study results showed that 89% of patients receiving Uplizna experienced no relapse during the 197-day follow-up period, demonstrating a 77.3% reduction in relapse risk compared to the placebo group. Safety assessments also showed a comparable rate of adverse events to the placebo group. Furthermore, in an extension study of this clinical trial, Uplizna continuously reduced the risk of relapse for at least 4 years, with a relapse-free rate of 87.7%. The long-term safety profile demonstrated generally good tolerability, and there was no increase in infection rates due to B-cell depletion. Meanwhile, NMOSD is a serious autoimmune disease in which most patients experience persistent relapses with incomplete recovery, leading to accumulated nerve damage that causes vision loss, gait impairment, and even death from respiratory failure.
- Product
- ‘Will promote phased implementation of INN prescriptions’
- by Kim JiEun Oct 01, 2025 06:10am
- Research Director Dae-Jin Kim, Korea Institute for Pharmaceutical Policy Affairs A study has shown that introducing an International Nonproprietary Name (INN) prescription system could save up to KRW 9 trillion annually in drug costs and related social expenses. At a policy forum on INN prescriptions held at the National Assembly on the 30th, Dae-jin Kim, Director of the Korea Institute for Pharmaceutical Policy Affairs (KIPPA), gave a presentation on “Plans for Introducing a Korean INN Prescription Model.” The forum was hosted by National Assembly members In-soon Nam, Young-seok Seo, Jong-tae Jang, Yoon Kim (Democratic Party of Korea), and Sun-min Kim (Rebuilding Korea Party), and organized by the Korean Pharmaceutical Association and KIPPA. Director Kim first pointed out that the excessive number of generic drug items in the domestic pharmaceutical market is increasing management costs and leading to waste in the National Health Insurance finances. As of January this year, 27.7% of all items had 61 or more products containing the same active ingredient. This directly leads to costs associated with stockouts, unused inventory, recalls, and disposal. He also criticized the structure where a non-differentiated generic industry is being sustained by health insurance finances. He further argued that the high proportion of expensive generics limits cost-saving effects, while the fact that most generic products are marketed under brand names reduces patients’ awareness of the active ingredient, creating communication difficulties between patients and healthcare professionals. This, in turn, heightens concerns about patient safety incidents. Criticism was also raised regarding restrictions on patient choice. Director Kim stated that the low generic substitution rate limits patients' opportunities to choose among medicines with the same ingredients and equivalent effects. Director Kim also presented the results of a survey on public awareness of INN prescribing. In this survey of 3,000 adult men and women residing in Korea, 18.3% reported experiencing drug shortages in the past year. Furthermore, in a survey on acceptance of the INN prescription system, 83.8% of respondents gave positive responses. Based on this domestic pharmaceutical situation and public perception, Director Kim proposed a Korean-style INN prescription model. He explained that its fundamental purpose is ‘to reduce national medical expenses and health insurance premiums while strengthening patient safety and rights’. Director Kim clarified that the definition of INN prescribing in this study refers to prescriptions that list only the ‘active ingredient code + INN + dosage form + strength’ without mentioning brand names. The application targets will be implemented in phases: Phase 1 covers ▲ingredient groups with unstable supply ▲ingredient groups frequently substituted during dispensing ▲the top 100 ingredient groups by claim volume. Phase 2 expands to 5 major efficacy groups (gastrointestinal, diabetes, hypertension, hyperlipidemia drugs, antibiotics, etc.), and Phase 3 extends to all pharmaceuticals. Prerequisites for the system were also outlined: ▲ Reducing domestic drug prices for identical ingredient groups to below the average price of overseas A8 countries ▲ Operating a National Health Insurance Service-recommended drug list and introducing differential co-insurance policies ▲ Improving the coninsurance system. Based on the research findings, Director Kim estimated the maximum annual economic effect of introducing this INN prescription system model at KRW 9.3641 trillion. This figure combines savings of KRW 7.9 trillion in drug costs and KRW 1.4741 trillion in reduced social costs. Director Kim stated, “It is necessary to prioritize applying this system to drug groups with high social demand and cost-effectiveness, then gradually expand the system thereafter. Above all, ensuring patients' right to know and their choice of medication is crucial. Measures to enhance patient access to information, such as utilizing mobile applications or electronic medication guides, can be considered.” He continued, “If fiscal efficiency measures like drug price reductions, differential copayments, and promoting generic competition are implemented alongside the system, they can contribute to reducing national health insurance expenditures. The INN prescription system, implemented in a Korean-style format, will be the core alternative. It strengthens patient safety and rights, reduces national medical expenses and health insurance premiums, and simultaneously addresses chronic issues in the domestic pharmaceutical market, such as the use of high-priced generics and excessive product variety.” Meanwhile, before the forum, the hosting lawmakers In-soon Nam, Young-seok Seo, and Jong-tae Jang each made remarks on the purpose and necessity of introducing the system. Rep. In-soon Nam said, “Public interest in INN prescriptions has grown since the COVID-19 pandemic prompted drug supply instability. I believe the introduction of INN prescriptions can be discussed not only as an alternative at the production and distribution stages related to supply instability issues, but also as an alternative at the prescription stage. Rep. Young-seok Seo said, “We must strive to ensure the system is implemented, considering whether it is necessary for the public and whether it should be introduced to improve the healthcare system. Given the current state of the global pharmaceutical market, supply instability is likely to worsen in the future. INN prescribing is expected to become a tool ensuring a stable drug supply and delivery to patients. I hope the pharmacy community can effectively persuade the public of this.” Korean Pharmaceutical Association President Young-hee Kwon emphasized, “INN prescriptions allow patients to know the ingredients of their medications and make rational choices, thus ensuring their right to choose and realizing the right to health. At the national level, it is also an alternative to reduce health insurance expenditure, secure sustainability, and expand coverage. From the perspective of public health and socioeconomics, it is an essential system demanded by the times.”
- Policy
- "Why are pharma developing salt changes called innovative?"
- by Lee, Jeong-Hwan Oct 01, 2025 06:10am
- Professor Yong Jin Kwon "There are no developed countries that provide public funds and National Health Insurance resources to pharmaceutical companies for simply changing salt formation. South Korea is the only country in the world that recognizes incrementally modified drugs as having the value of innovative new drugs. (If we want to call incrementally modified drugs innovative new drugs), The government should establish the concept of a super-innovative new drug and allocate funds to companies that develop truly innovative treatments. The National Health Insurance authorities shouldn't be worrying about Korean pharmaceutical companies; they should be preparing to spend hundreds of millions, or billions, of KRW from the NHI budget when a genuine domestic innovative treatment is developed." Criticism calls for a major shift in perspective among domestic pharmaceutical companies in Korea, the Ministry of Health and Welfare (MOHW), and the National Health Insurance Service (NHIS) to foster the Korean pharmaceutical industry and develop new domestic drugs into global blockbusters. The argument is that to produce domestic new drugs that meet the standards of the global market, the NHI authorities must establish an environment that invests limited national budgets and NHI funds into genuine new drugs, rather than salt-changed, incrementally modified drugs. Pharmaceutical companies must step up their investments in New Drug Research and Development (R&D). Immediately after the parliamentary forum, held on September 26, on improving NHI financial management, Professor Yong Jin Kwon of the Public Healthcare Center at Seoul National University Hospital met with DailyPharm and sharply criticized the government's new drug administration and the R&D direction of domestic pharmaceutical companies. Professor Kwon asserted that the current innovative new drug support policy of the Korean government is fundamentally flawed. He pointed out that Korea is the only country in the world to support these efforts with national budgets and NHI funds, recognizing the value of incrementally modified drugs based on salt changes. Professor Kwon emphasized that the Korean pharmaceutical industry must deeply reflect on the fact that it has grown significantly over the past 25 years, driven mainly by public health insurance premiums, yet failed to produce innovative new drugs during that period. "I believe that the presidential pledge for a drug price premium based on innovative new drug value is someone's lobbying work," Professor Kwon stated. "We need to have a conversation with the public about whether there is any developed country that gives NHI funds to companies that just change salt formation. I don't think (the domestic pharmaceutical industry) should be operating this way." He further pointed out, "Twenty-five years ago, when the National Health Insurance Act was introduced and the separation of prescribing and dispensing was implemented, domestic pharmaceutical companies made enormous net profits, eliminating all their debt until generic prices were cut in 2013." He criticized, "That's why structural reform of the pharmaceutical industry failed. There are no studies on how much of the R&D funding provided to pharmaceutical companies, which includes high generic drug prices paid by the public and government support from the MFDS, actually led to tangible results, and no one is looking into it." Professor Kwon said, "The R&D support budget for pharmaceutical companies is public tax money and insurance premiums. So, how much has the domestic pharmaceutical industry truly developed over the past 25 years?" He added, "We need to evaluate this before talking about developing the pharmaceutical industry. The NHIS shouldn't be worrying about domestic pharmaceutical companies. The NHIS should be pushing them to create proper rare disease drugs (new drugs)." Professor Kwon also proposed improving the financial soundness of the NHI by rationalizing the prices of generic drugs. It is to lower generic drug prices to an appropriate level relative to the original price and use the saved resources to support and expand investment in innovative drug development. Specifically, Professor Kwon suggested unilaterally reducing generic drug prices, which currently account for 53.55% of the original drug price, to a level of 30% to 40%, and mitigating the market shock through phased adjustments. It is believed that this redistribution of NHI finances could expand investment in innovative new drugs by two to three times without increasing the total medical expenditure. Professor Kwon said, "I strongly disagree with the NHIS's remark that we should reconsider the structural reform (reduction) of generic drug prices. The NHIS is the public's agent. If they look into where the public's NHI money has been wasted, I absolutely want to tell them that this is not the time to worry about domestic pharmaceutical companies," he asserted. "The Korean government and pharmaceutical companies must raise the competitiveness of the domestic pharmaceutical industry and be prepared to spend hundreds of millions, or billions, of KRW from the NHI budget when an innovative new drug is developed." Finally, Professor Kwon said, "How long will we continue to out-license all our new drug candidates and then have to slash prices when we bring them back from overseas markets? We are a developed country now." He added, "(The government) should improve the system by modifying the current actual transaction price reimbursement system and introducing a dual pricing system so that our new drugs can command high prices when exported to foreign markets."
- Company
- Will a new market for presbyopia open up?
- by Kim, Jin-Gu Oct 01, 2025 06:10am
- The market for age-related blurry near vision (presbyopia) treatment is emerging as a blue ocean for Korean pharmaceutical and biotech companies. Following a series of new drug approvals by the U.S. Food and Drug Administration (FDA), ophthalmic specialized pharmaceutical companies, including Dae Woo Pharmaceutical, OPTUS Pharma, and Kwangdong Pharmaceutical, are accelerating their efforts to introduce and develop treatments for presbyopia. Pilocarpine containing eye drop is expected to treat presbyopia...Dae Woo "We will also conduct clinical trials for expanded indication" According to the pharmaceutical industry on September 30, Dae Woo Pharmaceutical plans to concurrently conduct clinical trials to add presbyopia indication to its recently launched product, 'Pilostar Eye Drops 1%'. Dae Woo Pharmaceutical anticipates that the main component, pilocarpine, will be effective not only in treating glaucoma but also in improving presbyopia. Pilocarpine is a parasympathetic agonist that reduces intraocular pressure by promoting aqueous humor outflow through the trabecular meshwork. It also has a mechanism that contracts the iris sphincter muscle. This process reduces the pupil size, creating a pinhole effect that improves presbyopia, a principle similar to how an object becomes clearer when a camera's aperture is narrowed The U.S. FDA has actually approved an eye drop with the same ingredient as a presbyopia treatment. The U.S. FDA approved Vuity (developed by Allergan) as the first presbyopia treatment in 2021. Vuity, a presbyopia treatment with a 1.25% concentration of pilocarpine, improves presbyopia symptoms within 15 minutes of once-daily administration, with effects lasting for about 6 hours. Recent research results presented at the European Society of Cataract and Refractive Surgeons (ESCRS) are also increasing the success potential of pilocarpine-based presbyopia treatments. A research team from the Presbyopia Study Center in Buenos Aires, Argentina, presented results from administering pilocarpine-containing eye drops to 766 patients with presbyopia at the ESCRS conference in Copenhagen, Denmark, on September 8. The research team divided the clinical participants into three groups, administering 1%, 2%, and 3% concentrations of pilocarpine eye drops, respectively. Administered twice daily at 6-hour intervals, 99% of the group receiving the 1% concentration eye drops (148 participants) were able to read two or more additional lines on a vision test chart. A Dae Woo Pharmaceutical official stated, "We are paying close attention to the research results presented at recent global academic conferences. We are preparing clinical trials to add the presbyopia treatment indication." He added, "The clinical trial is expected to take 2-3 years." U.S. FDA approves treatments for presbyopia one after another…Korean companies, such as Kwangdong and Optus, compete for domestic launch Other pharmaceutical companies are also pursuing treatments for presbyopia. In particular, interest is growing in 'Vizz,' a new active ingredient presbyopia treatment approved by the U.S. FDA last month. This product is an ophthalmic solution with a 1.44% concentration of aceclidine, developed by LENZ Therapeutics, a U.S.-based company. The emergence of a new active ingredient for treating presbyopia has sparked competition among Korean pharmaceutical companies for its domestic launch. It is reported that 3-4 companies initiated discussions with LENZ Therapeutics for the domestic introduction of this product immediately after the FDA approval. (from left) Product photos of Vuity, Qlosi, and Vizz. OPTUS Pharma and Kwangdong Pharmaceutical have also actively pursued the introduction of presbyopia treatments. OPTUS Pharma signed a licensing agreement for the presbyopia treatment 'Qlosi' with Orasis Pharmaceuticals (U.S./Israel) in September of last year. This drug was the second presbyopia treatment approved by the U.S. FDA in October 2023. Its main component, like Vuity, is pilocarpine, but the concentration differs at 0.4%. Its domestic commercialization is expected as early as 2026. Kwangdong Pharmaceutical signed an agreement last January to introduce the presbyopia treatment candidate BRIMOCHOL from the Hong Kong pharmaceutical company Zhaoke Ophthalmology. Through this contract, Kwangdong Pharmaceutical secures exclusive domestic import, distribution, and sales rights for BRIMOCHOL. The original developer is the U.S. biotech company Visus Therapeutics, and global Phase 3 clinical trials have been completed. Kwangdong Pharmaceutical signed an agreement last January to introduce the presbyopia treatment candidate BRIMOCHOL from the Hong Kong pharmaceutical company Zhaoke Ophthalmology. Through this contract, Kwangdong Pharmaceutical secures exclusive domestic import, distribution, and sales rights for BRIMOCHOL. This drug is a combination drug containing carbachol (2.75%) and brimonidine tartrate (0.1%), which alleviates symptoms of presbyopia. It activates the parasympathetic nervous system while simultaneously inhibiting the sympathetic nervous system. Like other treatments, its mechanism improves presbyopia by constricting the pupil. The pharmaceutical industry is focusing on the growth potential of the presbyopia treatment market. Presbyopia is a typical degenerative eye disease in which the elasticity of the lens decreases, making it difficult to focus on near objects. While 70% of adults aged 40 and over experience discomfort due to presbyopia, there have been no dedicated treatments other than vision correction using specialized glasses or contact lenses. The introduction of new drugs in the form of eye drops is expected to become a new alternative to satisfy patients' unmet needs. A pharmaceutical industry official predicted, "Since there have been no treatment options in the presbyopia treatment area, the market presence is expected to be significant when new drugs emerge," and added, "Competition among Korean pharmaceutical companies for new drug introduction and development will intensify in the future."
