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- 2025-12-19 21:27:58
- 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."
- Company
- ‘COVID-19 vaccination essential for high-risk groups’
- by Son, Hyung Min Oct 01, 2025 06:09am
- Professor Jacob Lee, Division of Infectious Diseases at Hallym University Kangnam Sacred Heart Hospital The number of hospitalized COVID-19 patients over the past six months has been about threefold that of influenza, underscoring the renewed importance of vaccination, particularly for high-risk groups. Leading experts pointed out that vaccination not only prevents hospitalization and death but also lowers the risk of long COVID, recommending active participation in the simultaneous flu and COVID-19 vaccination campaign starting on the 15th of next month. On the 30th, Moderna Korea held a press briefing at the Novotel in Gangnam-gu, Seoul, emphasizing the importance of COVID-19 vaccination. COVID-19, a global acute respiratory infection since 2019, is now perceived largely as a mild illness thanks to the availability of vaccines and treatments. However, it still poses a threat to certain high-risk groups. High-risk groups for COVID-19 are those requiring special management due to a higher risk of severe illness or death upon infection. These primarily include the elderly (aged 65 and older), individuals with chronic conditions (hypertension, diabetes, cardiovascular disease, kidney disease, cancer, etc.), and immunocompromised individuals. The number of COVID-19 hospitalizations has been steadily increasing this year. In the past six months, COVID-19 hospitalizations have been about three times higher than influenza. Experts note that a large proportion of hospitalized COVID-19 patients are aged 65 or older, classified as high-risk. In 2024, 19,562 elderly patients (65+) were hospitalized with COVID-19, compared with 6,205 influenza patients—roughly a threefold difference. Because high-risk groups face greater risks of severe disease when infected, vaccination and careful health management remain crucial. Leading experts, including the Korean Society of Infectious Diseases, recommend regular updated COVID-19 vaccinations for high-risk groups. This is because immunity acquired through infection or vaccination diminishes over time, and new variants emerge. Professor Jacob Lee of the Division of Infectious Diseases at Hallym University Kangnam Sacred Heart Hospital said, “Vaccination not only prevents hospitalization and mortality but also reduces the risk of long COVID by 58% according to reports. COVID-19 is a disease with long-term sequelae. Like influenza, it requires ongoing management.” He added, “COVID-19 and influenza vaccinations will begin simultaneously on October 15. Vaccination this year is necessary to control infectious disease outbreaks next winter.” Sang-Pyo Kim, CEO of Moderna Korea, stated, “We will prioritize the stable supply of COVID-19 vaccines, with the primary goal of protecting high-risk patients, including the elderly aged 65 and above.” Moderna will continue supply of vaccines targeting new variants Francesca Ceddia, Chief Medical Affairs Officer, Moderna Korea Moderna has been continuously supplying vaccines in Korea that target new variants. Recently, a new variant-specific vaccine also received domestic approval. In May, the Ministry of Food and Drug Safety authorized “Spikevax LP Inj,” a COVID-19 vaccine targeting the LP.8.1 variant. Spikevax targets the spike protein on the surface of the coronavirus. This protein binds to ACE2 receptors in the body, enabling viral entry and causing COVID-19 symptoms. Spikevax's mechanism involves injecting the viral antigen gene in mRNA form, causing the body to synthesize an antigen protein with the same spike structure. This protein induces the production of neutralizing antibodies, preventing the coronavirus from binding to the ACE2 receptor when it invades the human body, thereby neutralizing and eliminating the virus. The newly approved Spikevax LP Inj has shown continued effectiveness in Phase IV real-world data. In clinical studies involving adults aged 12–64 with underlying conditions and seniors aged 65+, neutralizing antibody levels against the LP.8.1 variant increased more than eightfold following vaccination. Francesca Ceddia, Chief Medical Affairs Officer at Moderna Korea, emphasized, “Moderna’s COVID-19 vaccines have been administered to patients worldwide, with both efficacy and safety confirmed. We also observed high immunogenicity comparable to that of the COVID-19 vaccine alone when administered concurrently with the flu vaccine.”
- Company
- Ozempic supply begins in Korea…co-promo partner 'undecided'
- by Hwang, byoung woo Sep 30, 2025 06:14am
- As discussions on National Health Insurance reimbursement for Ozempic (semaglutide), a diabetes treatment by Novo Nordisk, accelerate, attention has been garnered to the company's sales and marketing strategy in Korea. Product photo of OzempicNovo Nordisk has stated that the company has not finalized a co-promotion partnership with a domestic company in Korea. Yet, the possibility remains open, particularly after signing a co-promotion deal for the same-ingredient obesity treatment, Wegovy, with Chong Kun Dang. According to the pharmaceutical industry, Novo Nordisk Korea has decided to begin supplying Ozempic (semaglutide) to the Korean market on a non-reimbursed basis, starting on September 25, despite ongoing negotiations for National Health Insurance reimbursement. Ozempic, approved in Korea in April 2022, is a long-acting, once-weekly GLP-1 injectable indicated as an adjunct to diet and exercise, either alone or in combination with other diabetes treatments, for adults with insufficiently controlled Type 2 diabetes. Novo Nordisk previously applied for the reimbursement of Ozempic in 2023 but withdrew its application during the final stage of negotiations with the National Health Insurance Service (NHIS) over drug prices. Analysis suggests that uncertainties in domestic product supply have complicated the negotiation process over expected usage volume and prevented reimbursement, ultimately resulting in the failure to obtain reimbursement. Novo Nordisk's decision to initiate non-reimbursed supply now is likely interpreted as a sign of high expectations for a successful reimbursement listing. Novo Nordisk Korea is reportedly preparing to resubmit its reimbursement application to the Health Insurance Review & Assessment Service (HIRA). The company is awaiting deliberation by the Drug Reimbursement Evaluation Committee (DREC) in the near future. An anonymous professor of endocrinology at a major hospital in Seoul said, "Compared to the case in 2023, expectations for Ozempic's reimbursement listing are high," and added, "Although I can't confirm if it will succeed, I understand they proposed a reasonable price, and based on the collective opinion of the pharmaceutical industry and academic societies, I see a high possibility of success." In 2023, the Korean Diabetes Association and the Korean Endocrine Society recommended to the DREC that Ozempic, as a long-acting GLP-1 receptor agonist, should be granted the scope of reimbursement coverage comparable to Trulicity, a drug in the same class that has been subject to a clinical comparative study. The DREC gave conditional approval for reimbursement appropriateness, subject to the condition that the company accepts a price below the evaluated amount. And, Novo Nordisk accepted this condition. Although the DREC approval and negotiation with the NHIS remain, there is speculation that Ozempic's reimbursement price will be set similarly to, or slightly higher than, that of Trulicity. As discussions for Ozempic's reimbursement are imminent, the potential for a co-promotion partnership with a Korean pharmaceutical company is also drawing attention. Indeed, on September 18, Novo Nordisk signed a co-promotion agreement for the obesity treatment Wegovy with Chong Kun Dang. Through this agreement, the two companies will jointly conduct sales and marketing for Wegovy, targeting hospitals and clinics starting October 1. Novo Nordisk stated that it will maintain the same distribution approach for Ozempic as it did during the initial phase of Wegovy's launch. A Novo Nordisk official said, "We plan to distribute Ozempic through Zuellig Pharma in Korea, similar to Wegovy's case," and confirmed that "nothing has been decided regarding co-promotion or additional sales partnerships." However, the pharmaceutical industry predicts that Novo Nordisk will use the same distribution network to stabilize the initial market entry of Ozempic quickly and will discuss the possibility of co-promotion in detail after reimbursement is secured. This is because of a competing treatment, Lilly's Mounjaro (tirzepatide). Lilly is also pursuing reimbursement for Mounjaro's diabetes indication, and discussions about a potential co-promotion partnership are ongoing. The pharmaceutical industry generally believes that Novo Nordisk will pursue a co-promotion strategy for Ozempic, similar to the one used for Wegovy, to focus on the drug's expansion potential. A Novo Nordisk Korea official said, "The priority access of Ozempic is a result of our strong commitment and patient-centric efforts to provide it to Korean patients with Type 2 diabetes and healthcare professionals as quickly as possible," and added, "Simultaneous with the supply commencement, we are closely consulting with regulatory authorities to secure National Health Insurance approval for Ozempic to improve patient access to treatment."
- Opinion
- [Reporter's View] 'National Core Tech' status for Botox
- by Hwang, byoung woo Sep 30, 2025 06:13am
- The discussion regarding delisting botulinum toxin as a National Core Technology continues to yield no results. Despite increasing demands from the industry, regulatory reform has not improved. The arguments for and against lifting the listing continue, and the discussion has not advanced. In a National Assembly forum on September 29, the industry and civil society groups advocating for delisting spoke unanimously. "Overlapping regulations cause delays in research and development and hindering investment attraction." Key concerns raised at the forum included the lack of transparency in the criteria for designation and delisting, as well as the unpredictable timeframes involved. Critics also pointed out that the process, which requires review by multiple government ministries, increases the burden on companies, leading to wasted time and cost. Ultimately, critics argued that classifying an already commercialized technology as a National Core Technology undermines global competitiveness. Indeed, a survey presented at the forum showed that 82% of responding companies favored delisting. This suggests that the call to lift the designation is more a consensus across the industry rather than a simple demand. This situation even led to the sharp term 'regulatory capture' being used during the discussion, reflecting a mistrust that the purpose of the regulation has morphed from industry protection into maintenance. However, the Ministry of Trade, Industry and Energy, which was present at the meeting, expressed caution, stating that while they agree on the need for improvement, they "must hear opposing opinions as well as those in favor." Questions remain about whether the government, which is the only neutral party that can maintain balance between conflicting opinions, is actively fostering the discussion. It appears the situation requires the government to go beyond merely "listening to opinions" and actively planning and coordinating the debate. Without an active control tower, the discussion is not advancing. The solution is clear: The designation and delisting procedures must be standardized and the time required for the process must be disclosed transparently. A permanent consultative body involving industry, academia, and government must establish rational criteria, and if necessary, consider a phased or differentiated management approach. In this process, the government must act as the accountable facilitator, balancing the views of both sides and connecting them to an actionable roadmap. The longer the discussion drags on, the greater the anxiety for the industry and the higher the risk of falling behind in global competition. To halt this cycle of stagnation, the government must take action. What's needed now is not a reconfirmation of the pros and cons of delisting, but the government's decision and leadership.
- Policy
- First lot of returning nasal spray flu vaccine approved
- by Lee, Tak-Sun Sep 30, 2025 06:12am
- FluMist labelThe nasal spray flu vaccine ‘FluMist Intranasal Spray (AstraZeneca Korea)’ has received shipment approval from the Ministry of Food and Drug Safety (MFDS) and is preparing for sales. This product was previously sold by GC Biopharma, but it did not gain significant popularity at the time. With expected demand from children who dislike injections, attention is on whether it will avoid repeating its past failure. On the 26th, the Ministry of Food and Drug Safety granted shipment approval for FluMist Intranasal Spray (live attenuated influenza vaccine), lot number YK2763C (expiration date January 8, 2026). This is the first shipment approval since it was licensed in April this year, signaling the start of full-scale supply ahead of the flu season. FluMist Intranasal Spray is a trivalent vaccine preventing three viruses (influenza A H1N1, H3N2, and influenza B Victoria). It can be administered to children and adults aged 24 months to 49 years. Safety has not been established for children under 24 months. For those aged 50 and older, administration is prohibited in high-risk groups with underlying conditions, as the incidence of pharyngitis was higher compared to placebo. Nevertheless, this vaccine is gaining attention because it offers convenience in administration, particularly for children who dislike injections. This vaccine is a spray product that delivers the solution into the nose, which is expected to improve acceptability among children and make administration easier for providers. At a press conference celebrating the vaccine’s approval in June, Professor Yoon-Kyung Kim (Pediatrics, Korea University Ansan Hospital) said, “FluMist is a painless vaccine delivered by nasal spray that can contribute to increasing flu inoculation rate among children.” However, as it is not included in the National Immunization Program (NIP), demand is expected to fluctuate depending on pricing. When GC Biopharma launched the product in 2009, demand was low because it cost KRW 5,000–10,000 more than injectable vaccines. As a result, its license was revoked in July 2020 after the validity period expired. Another barrier is that intranasal vaccines are not yet familiar to the public, which could also affect uptake. Still, expectations remain that it could raise pediatric flu vaccination rates and contribute to herd immunity, thereby protecting the elderly from infection. A pharmaceutical industry official said, “Ultimately, pricing will impact sales volume. But unlike in the past, there is now demand for non-reimbursed vaccines that emphasize quality, so if the price gap is small, FluMist could gain a foothold in the market.”
- Company
- Three Korean Pharmas avoid Equfina patent
- by Kim, Jin-Gu Sep 30, 2025 06:12am
- Generic companies have succeeded in avoiding the patent of Eisai Korea’s Parkinson’s disease treatment Equfina (safinamide). With early generic launches drawing closer, competition for the first-generic exclusivity among patent challengers is expected to intensify. According to industry sources on the 29th, the Intellectual Property Trial and Appeal Board recently ruled in favor of three companies—Bukwang Pharm, Myung In Pharm, and Samil Pharmaceutical—by granting their requests for a negative scope confirmation trial against NurrOn Pharmaceuticals concerning Equfina’s patent (No. 10-1491541). Equfina is Eisai Korea’s adjunctive therapy for patients with idiopathic Parkinson’s disease experiencing motor fluctuations. It is used alongside levodopa-containing regimens. The patent holder is NurrOn Pharmaceuticals. Two patents related to Equfina are listed in the Ministry of Food and Drug Safety’s green list. Of these, the “method of treating Parkinson’s disease” patent expired in December last year. The patent expiring in 2028 has now been avoided by generics, and this recent victory reduces the burden for patent challengers applying for generic product approvals. The three companies that successfully avoided the patent are expected to compete for exclusive marketing rights. They have simultaneously satisfied two of the three requirements for obtaining exclusive rights: ‘filing the first patent invalidation petition’ and ‘winning that petition’. If they meet the remaining requirement of ‘being the first to apply for generic approval’, they can monopolize the generic market and exclusively sell their generics for 9 months. Among them, Myung In Pharm is known to be closest to securing exclusivity. The company began a bioequivalence trial in July and has already completed subject enrollment. Bukwang Pharm received approval for a bioequivalence study earlier this month. Samil Pharm has not yet initiated such a trial. All three companies have strong CNS portfolios, suggesting intense competition upon their generics’ launch. Given that the drug is used as adjunctive therapy with levodopa, synergy with existing products is also anticipated. Myung In Pharm already markets Parkinson’s treatments such as Myungdopar (levodopa/benserazide), Perkin (levodopa/carbidopa), and Trilevo (levodopa/carbidopa/entacapone). Samil Pharm sells Onedopa (levodopa/benserazide). Bukwang Pharm launched the schizophrenia/bipolar disorder drug Latuda last year, strengthening its CNS portfolio. Equfina is a third-generation MAO-B (monoamine oxidase-B) inhibitor that acts on both dopaminergic and non-dopaminergic pathways. Eisai received marketing approval in Korea in June 2020 and launched with reimbursement in February 2021. Import sales grew from USD 770,000 in 2021 to USD 2,070,000 in 2023, a 2.7-fold increase in just 2 years.
