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- 2026-03-10 00:45:09
- Policy
- Gvn’t ‘Reviewing various measures to address drug shortages’
- by Lee, Jeong-Hwan Jan 30, 2026 11:00am
- The Ministry of Health and Welfare (MOHW) has clarified that it is not relying solely on International Nonproprietary Name (INN) prescribing as a solution to addressing Korea’s drug shortages.The ministry stated that its administrative goal is to identify the underlying causes and develop appropriate, stage-specific policy tools to address drug shortages in a targeted manner, in consideration of the varying causes of Korea’s unstable drug supply.It also presented a plan to establish a social governance framework to resolve the unstable supply of medicines. This will involve operating a discussion table where doctors, pharmacists, the government, pharmaceutical companies, and patients all participate, aligned with the implementation of the revised Pharmaceutical Affairs Act.On the 29th, Jun-hyuk Kang, Director of the Division of Pharmaceutical Policy at MOHW, stated at a National Assembly policy forum on INN prescribing for supply-unstable medicines that “the government does not believe that drug supply instability can be resolved solely through INN prescribing.”Kang emphasized that shortages arise from a wide range of factors, including manufacturing, distribution, prescribing, and dispensing, and that the government will identify the root causes and develop appropriate measures to address them.Kang further noted that while past government policies focused on establishing systems to foster the pharmaceutical industry, future efforts will involve administrative support for the industry from a national health security perspective to resolve the issue of unstable drug supply.Kang said, “While there have been efforts to foster the industry in the past, there has never been support for active pharmaceutical ingredients from a public health security perspective. We have pointed out issues such as import dependency and shortage monitoring, and we are strengthening measures on that part as well, including requiring pharmaceutical companies to report supply disruptions.”He added, “Regarding drug pricing, while we've emphasized the specificity of drugs until now, the drug pricing system announced late last year will set prices reflecting contributions to alleviating supply instability. The Ministry of Health and Welfare is examining diverse causes of supply instability and considering phased policy measures accordingly.”Regarding governance mechanisms for addressing drug shortages, Kang stated that although such a structure did not previously exist, it will be established with the enforcement of the amended Pharmaceutical Affairs Act.“There is currently a consultative body under the Pharmaceutical Affairs Act, but it is structured for government-only participation in maintaining the healthcare system. However, the revised Act, which takes effect late this year, provides for a new governance framework. It establishes criteria for essential medicines and enables responses to supply-unstable drugs.”He added, “We have created a structure where representatives recommended by medical associations, pharmacist associations, and patient groups can join and discuss issues related to drugs with unstable supply within this governance framework. Regarding drug usage, we are building a substitution dispensing information system. This will streamline the substitution dispensing process within the legally defined standards, improving convenience for both physicians and pharmacists.He added, “INN prescribing is not being discussed solely for cost savings. The government is considering INN prescribing only for essential medicines, from the standpoint of ensuring treatment continuity for patient life and health. The government is not viewing INN prescribing as the sole solution to supply instability.”
- Company
- Multinational pharma union 'We oppose drug pricing reform'
- by Son, Hyung Min Jan 30, 2026 11:00am
- On January 29, the Korean Democratic Pharmaceutical Union (KDPU) held a picket protest in front of the Health Insurance Review & Assessment Service (HIRA) in Seocho-dong, Seoul.Both domestic pharmaceutical companies and labor unions of multinational pharmaceutical corporations in Korea have strongly opposed the government's proposed drug pricing reform.The pharmaceutical industry is calling for a reconsideration of the drug pricing reform policy, claiming that the proposal will directly lead to job insecurity, reduced R&D investment, and disruptions in the supply of essential medicines.At 1:00 PM on the 29th, ahead of the Health Insurance Policy Deliberation Committee meeting, the Korean Democratic Pharmaceutical Union (KDPU) held a picket protest in front of the Health Insurance Review & Assessment Service (HIRA) in Seocho-dong, Seoul. The KDPU, an organization composed of labor union members from major multinational pharmaceutical companies, took action to deliver the message about the impact the government's drug pricing reform would have."The nightmare of the 2012 layoff will repeat"The protest site was lined with pickets warning of the policy's impact, featuring slogans such as "If domestic medicine disappears, national health also disappears," "Chasing cheap drug prices leads to limited access to essential medicine," and "Drug price cuts cost the livelihood of workers." The KDPU specifically stated that workers at multinational firms also perceive this drug pricing reform as a direct employment risk.Park Ki-il, Chairman of the KDPU, stated, "The pharmaceutical union was created because of the large-scale restructuring at each company triggered by the 2012 drug price cuts," added, "At that time, companies began downsizing, and even now, the pharmaceutical industry is exposed to the risk of restructuring due to constant drug price reductions. The impact of this reform may be even greater than back then."In particular, Park pointed out that the government is overlooking the structural risk of 'revenue decrease → R&D reduction → cessation of essential medicine production.'Park emphasized, "If the prices of all products are forcibly lowered, revenue will inevitably decrease, and if there is no profit, R&D investment stops." He added, "Companies may give up production of drugs that are not financially viable. This is an issue that could lead to supply disruptions even for essential medicines."Picket protest by the Korean Democratic Pharmaceutical Union (KDPU). He also expressed concern regarding the government's proposed restructuring of the generic drug pricing structure.Park criticized, "If generic drug prices are reduced to around 40%, it will eventually put pressure to lower the prices of original products even further. This is a measure that shakes the profit structure of the entire industry."Furthermore, he stated that the government is interpreting the issue of CSO (sales agency) costs in an excessively simplified manner.Park stated, "Judging that the entire industry is affluent just because some companies spend heavily on CSO costs is an error. We have consistently demanded improvements from companies because such misunderstandings could lead to further drug price cuts."He continued, "Drug price cuts without employment stability measures are a disaster for both workers and the industry. If the government truly cares about public safety, it must completely reconsider the policy."Concerns over large-scale layoffs and weakening industrial competitivenessThe Federation of Korean Chemical Workers' Unions, to which the KDPU belongs, issued a statement on the 15th strongly opposing the government's proposed drug pricing system reform, claiming it fails to adequately reflect the characteristics of the pharmaceutical industry and the realities of labor.The Federation emphasized that the pharmaceutical industry has a high employment-to-revenue ratio and analyzed that if drug price cuts are realized, there is a possibility of approximately 14,000 job losses, centered on research, production, quality, and sales positions.In particular, they pointed out that, given the industry characteristic of fixed costs accounting for a large share, a decrease in revenue can directly lead to workforce reductions and the expansion of irregular positions, making a negative impact on local economies inevitable.The Federation also emphasized that, contrary to the government's goal of creating a new drug development ecosystem, expanding R&D in a situation of decreasing profits is unrealistic.In fact, the net profit margin of the top 100 domestic pharmaceutical companies is only around 3%. If the reform is implemented as initially proposed, an annual revenue decline of up to KRW 3.6 trillion is expected, further reducing the capacity for R&D investment.The Federation demanded that the government ▲reconsider the drug pricing system reform ▲establish a social discussion body in which labor unions participate ▲prepare employment stability measures ▲establish comprehensive measures linked to R&D and strengthening the competitiveness of domestic pharmaceuticals.Picket protest by the Korean Democratic Pharmaceutical Union (KDPU). Park Ki-il (on the right), Chairman of the KDPU, argued for full reconsideration of the drug pricing system reform
- Company
- Will the topical JAKi Anzupgo cream be reimbursed?
- by Eo, Yun-Ho Jan 30, 2026 11:00am
- Interest is growing in the potential inclusion of the topical JAK inhibitor ‘Anzupgo Cream in Korea’s national health insurance reimbursement system.According to industry sources, LEO Pharma Korea’s novel therapy Anzupgo (delgocitinib) for chronic hand eczema (CHE) is expected to be reviewed by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) in the first half of this year. LEO Pharma submitted its reimbursement application shortly after receiving Ministry of Food and Drug Safety (MFDS) approval in September last year.It remains to be seen whether this will lead to the introduction of the first reimbursed topical JAK inhibitor in cream formulation in Korea.Anzupgo is the only approved non-steroidal topical cream indicated for the treatment of moderate-to-severe chronic hand eczema in adults who do not respond adequately to topical corticosteroids or for whom such therapies are not appropriate.The product contains no parabens or steroids and exerts its therapeutic effect by inhibiting the JAK-STAT signaling pathway, which plays a key role in multiple inflammatory responses. By suppressing the activity of JAK1, JAK2, JAK3, and TYK2, Anzupgo helps alleviate skin inflammation and pruritus.Until now, treatment options for chronic hand eczema have been limited, primarily relying on potent topical steroids. However, their long-term use carries risks of various side effects, including skin barrier damage, skin atrophy, and telangiectasia.For this reason, when short-term effects are not observed, Korean treatment guidelines recommend combination therapy with topical calcineurin inhibitors or systemic corticosteroids.Currently, the only approved oral treatment for severe chronic hand eczema is GSK’s Alitoc (alitretinoin), which is indicated for patients who do not respond to at least four weeks of intensive topical corticosteroid therapy. It improves symptoms through skin regulation, anti-inflammatory, and immunomodulatory actions. It is known to be effective for long-term management of chronic severe hand eczema with a high risk of recurrence.However, its long-term use is limited by concerns over hepatotoxicity, hypothyroidism, dyslipidemia, and teratogenicity, which restrict sustained treatment.Meanwhile, the efficacy of Anzupgo has been demonstrated in the DELTA FORCE and DELTA 2 clinical trials, which directly compared delgocitinib with GSK’s Alitoc (alitretinoin).In the DELTA FORCE study, delgocitinib demonstrated superiority over alitretinoin capsules when evaluated using the Hand Eczema Severity Index (HECSI) at baseline and Week 12, meeting the primary endpoint.The DELTA 2 trial enrolled 473 patients with moderate-to-severe chronic hand eczema. Participants were randomized to receive either delgocitinib cream or placebo cream, applied twice daily for 16 weeks.The primary endpoint was defined as an Investigator’s Global Assessment for Chronic Hand Eczema (IGA-CHE) score of 0/1 measured at Week 16 of treatment. Key secondary endpoints included IGA-CHE and Hand Eczema Symptom Diary (HESD) scores assessed at Week 4 and 8.Results showed that the delgocitinib group demonstrated statistically significant improvement in chronic hand eczema at Week 16 compared with placebo, successfully meeting both the primary and key secondary endpoints.
- Company
- 'Expanded reimb for Keytruda…expected to improve solid cancer treatment performance'
- by Son, Hyung Min Jan 30, 2026 10:59am
- Professor Keun-Wook Lee of the Department of Hematology and Oncology at Seoul National University Bundang HospitalThe immune checkpoint inhibitor Keytruda is bringing a major shift in the oncology treatment landscape in Korea following expanded scope of reimbursement across major solid tumors.Of the 11 indications included in the reimbursement scope, evaluations suggest that the potential to improve patient access and survival outcomes has increased in areas where existing treatment options were limited.On the 29th, MSD Korea held a press conference at Seongam Art Hall in Gangnam-gu, Seoul, to commemorate the expansion of reimbursement for Keytruda (pembrolizumab).Starting from the 1st of this month, Keytruda's reimbursement in Korea has been expanded to a total of 11 indications, including metastatic HER2-positive and negative gastric cancer, recurrent and metastatic triple-negative breast cancer (TNBC), head and neck cancer, and endometrial cancer.As MSD's flagship immunotherapy targeting PD-1, Keytruda has proven clinical evidence across various solid tumors, and this reimbursement adjustment is drawing industry attention as it covers cancers with high unmet medical needs.Professor Keun-Wook Lee of the Department of Hematology and Oncology at Seoul National University Bundang Hospital emphasized the importance of expanding Keytruda's reimbursement for gastrointestinal cancers, including gastric and colorectal cancers.Patient access to Keytruda has improved, as reimbursement is now available for major gastrointestinal cancers, including HER2-positive gastric cancer, first-line treatment for HER2-negative gastric cancer with PD-L1 CPS 10 or higher, and microsatellite instability-high (MSI-H) colorectal cancer.Professor Lee evaluated, "Keytruda's accessibility has improved as it is now reimbursed for major gastrointestinal cancers," and added, "Considering the characteristics of these cancers, which are directly linked to eating, digestion, and bowel functions and cause great discomfort in life, this expansion is a crucial turning point for patients."Professor Min Hwan Kim of the Department of Hematology and Oncology at Severance HospitalProfessor Lee added, "Reimbursement to minority patient groups such as MSI-H is a meaningful achievement from both clinical and institutional perspectives."Professor Min Hwan Kim of the Department of Hematology and Oncology at Severance Hospital mentioned major clinical evidence in female cancers, such as breast and endometrial cancer.Professor Kim stated, "Keytruda demonstrated meaningful therapeutic effects in metastatic endometrial cancer for the first time in about 50 years, and clearly showed improvement in survival duration compared to conventional therapies even in triple-negative breast cancer, which has a very poor prognosis."Professor Kim explained, "Keytruda confirmed meaningful treatment outcomes in metastatic settings based on sustained responses, which can lead to prolonged survival and improved quality of life."Beyond immunotherapy toward ADCs and targeted therapies, MSD's R&D strategy is acceleratingImmune checkpoint inhibitor to ADC and targeted cancer drugSoo Jung Kim, Executive Director of the Medical Affairs Department at MSD KoreaMSD Korea is strengthening domestic access to cancer treatment and developing innovative new drugs, starting with this reimbursement expansion.MSD is also making efforts to improve administration convenience by developing a subcutaneous (SC) formulation of Keytruda, named 'Keytruda QLEX.'Soo Jung Kim, Executive Director of the Medical Affairs Department at MSD Korea, said, "Keytruda holds more than 40 indications across 18 cancer types. It has changed the paradigm of cancer treatment by improving survival duration in various cancers," and noted, "In the case of Keytruda QLEX, administration is possible in just two minutes. This will significantly increase patient convenience."Kim added, "More than 30 global Phase 3 clinical trials for new oncology drugs are underway. We are expanding our R&D portfolio not only in immunotherapy but also in the fields of targeted therapy and antibody-drug conjugates (ADC)."MSD entered into a joint ADC development agreement with Daiichi Sankyo in 2023 and secured global rights (excluding Japan) for three candidate materials ▲patritumab deruxtecan ▲ifinatamab deruxtecan ▲raludotatug deruxtecan.In particular, clinical research on the B7-H3-targeting ADC 'ifinatamab deruxtecan' is underway to establish a new combination for small cell lung cancer through combination strategies with MSD's bispecific antibody 'MK-6070.'MSD is also conducting global Phase 3 trials for the ADC 'MK-2870.' MK-2870 targets Trop-2 and is being developed with the goal of securing an indication for triple-negative breast cancer. This ADC is a candidate material that MSD in-licensed from China's Kelun-Biotech in 2022 for $1.41 billion.MSD is also actively pursuing next-generation combination strategies linking immunotherapies, targeted therapies, and cancer vaccines.Albert Kim, CEO of MSD Korea, said, "Keytruda's expanded reimbursement is the result of everyone's cooperation to create a healthy tomorrow for patients," and added, "We will continue to prioritize patient-centered treatment accessibility as our top value and actively participate in creating clinical evidence and discussions."
- Company
- Epkinly, a new bispecific antibody for DLBCL, enters the drug negotiation stage
- by Eo, Yun-Ho Jan 29, 2026 08:17am
- Epkinly, new T-cell-engaging bispecific antibody drug, has entered the final stage for insurance reimbursement listing.According to industry sources, AbbVie Korea is currently conducting drug price negotiations with the National Health Insurance Service (NHIS) for the diffuse large B-cell lymphoma (DLBCL) treatment Epkinly (epcoritamab).Epkinly was approved in Korea in June 2024 and obtained designation as an orphan drug by the Ministry of Food and Drug Safety (MFDS).Epkinly is a humanized bispecific antibody (IgG1) that binds to specific extracellular epitopes of CD20 on B-cells and CD3 on T-cells.The drug induces specific T-cell activation and T-cell-mediated killing of CD20-expressing cells by simultaneously acting on cancer cells expressing CD20 and on T-cells expressing CD3.The efficacy of Epkinly was demonstrated in the EPCORE NHL-1 study, a non-randomized, single-arm clinical trial involving 167 patients with relapsed or refractory large B-cell lymphoma who had received 2 or more systemic therapies.Three-year follow-up results from the EPCORE NHL-1 study showed an overall objective response rate (ORR) of 59% and a complete remission (CR) rate of 41%, confirming that more than half of patients who achieved CR maintained their remission after three-years.Professor Deok-hwan Yang of the Department of Hematology at Chonnam National University Hwasun Hospital stated, "Epkinly, a bispecific antibody treatment, not only showed a complete remission rate similar to CAR-T treatments but can also be administered to patients immediately at medical institutions without a separate manufacturing period. As it targets a different antigen than CD19-targeting CAR-T treatments, the emergence of a new treatment option for patients who have failed CAR-T therapy is favorable."Meanwhile, the topline results of AbbVie's Phase 3 EPCORE DLBCL-1 study was disclosed recently. This study was conducted on 483 patients with relapsed or refractory DLBCL who had received one or more prior treatments and were ineligible for high-dose chemotherapy and autologous stem cell transplantation (HDT-ASCT).According to the topline results, Epkinly improved progression-free survival (PFS) by 26%. However, it failed to demonstrate an improvement in overall survival (OS), which was the primary endpoint.
- Policy
- "No drugs available for pediatric obesity…low dose phentermine combi as an option"
- by Lee, Jeong-Hwan Jan 29, 2026 08:17am
- On January 2, Rep. Seo Mi-hwa of the Democratic Party and the Korean Society for the Study of Obesity (KSSO) co-hosted a policy forum at the National Assembly Hall. Rep. Park Jie-won, a running candidate for the next National Assembly Speaker, attended to give a congratulating remarks.The medical community demanded the establishment of a regulatory track to allow limited prescribing of the psychotropic appetite suppressant phentermine·topiramate combination (Qsymia) in cases where the purpose of treating pediatric diseases, such as high-risk groups for adult-onset diseases, is clear.They argued that while obesity drugs such as GLP-1 analogs that can be used for pediatric patients aged 12 and older exist, they present challenges such as the difficulty of the injectable formulation and high medication costs; therefore, treatment options must be expanded by extending the indication for the low-dose phentermine and topiramate combination to those aged 12 and older.The Ministry of Food and Drug Safety (MFDS) understood the demands of prescribing clinicians and academia. Yet, it stated that the social controversy surrounding 'medical narcotic addiction' cannot be completely ignored.The MFDS explained that if a prescribing physician explains that the administration was for the purpose of treating a disease, the administration of narcotic appetite suppressants is possible even for pediatric patients.At the policy forum for expanding opportunities for pediatric obesity treatment medications, held on the 27th and hosted by the KSSO and Rep. Seo Mi-hwa of the Democratic Party, healthcare experts and the regulatory authority, the Ministry of Food and Drug Safety, met to exchange views on expanding the prescription of the phentermine/topiramate combination.Rep. Park Jie-won of the Democratic Party, the oldest active member of the National Assembly and a leading candidate for the next National Assembly Speaker, also attended the forum to support expanding obesity treatment options and to deliver congratulatory remarks.Rep. Seo Mi-hwa said, "Rep. Park Jie-won is the person who led me into politics," and added, "Along with Rep. Park, I will carefully review the opinions of medical sites and experts who believe that expanding treatment options for severe pediatric obesity is necessary.""Time to consider prescription options for pediatric patients aged 12 and older, even with restricted prescription conditions"Professor Hea Young Cho of the CHA University College of Pharmacy, who serves as the President of the Korean Society of Pharmaceutical Sciences and Technology (KSPST), appealed for the great necessity of creating a regulatory track to allow limited administration to pediatric patients aged 12 and older, highlighting Qsymia's low dependence and its clinically proven weight loss efficacy.In particular, Professor Cho noted that while the approval for phentermine monotherapy is set at age 16 and older, the reality that the low-dose phentermine·topiramate combination is more tightly regulated at age 18 and older has some irrational aspects.Professor Cho explained, "Phentermine monotherapy can be prescribed from age 16, yet the topiramate combination therapy is instead mandated for use in patients aged 18 and older," and added, "I wondered why this was the case. The prescription regulation for the combination is higher despite its lower phentermine content."Professor Cho further added, "Topiramate sustains weight loss effects by increasing satiety or stabilizing eating habits. Psychotropic components were developed as combination drugs to produce synergistic effects while lowering the dosage," and added, "Regarding dependence, the U.S. FDA manages the phentermine combination as Schedule IV, which is classified as having the lowest dependence."Professor Cho emphasized, "Because the weight loss effect of the low-dose phentermine combination has been scientifically proven, a relaxed prescription track must be created so that if necessary for pediatric treatment, the drug can be used while tracking and managing results through clinical monitoring," and added, "One way is to use a flexible prescription policy, such as lowering the prescription age for the phentermine combination by imposing limited prescription conditions and requiring sufficient clinical cases."Professor Hea Young Cho , Professor Park Jung-Hwan , Director Lee Jae Hyuk of the Korea Regulatory Affairs Professionals Society (from left)Professor Park Jung-Hwan of the Department of Endocrinology and Metabolism at Hanyang University Hospital, who serves as a director on the Committee of External Affairs and Policy of the KSSO, also urged the MFDS, the regulatory authority for the phentermine combination, not to take all management responsibility but instead grant obligations to prescribing doctors or selling pharmaceutical companies to operate the prescription age range flexibly.Professor Park said, "The use of low-dose phentermine combinations must be activated for pediatric patients. There is a case of a patient where we prescribed semaglutide up to stage 5, costing millions of won. However, the patient did not lose even 1kg of body weight," and added, "There are cases where phentermine·topiramate works for such patients."Professor Park stated, "Although semaglutide has been approved for use in pediatric patients, the reasons for obesity are diverse, so it would be good to relax the prescription age standards to accumulate and observe the necessary data and safety for the country," and "Rather than posing prescription restrictions, wouldn't it be more appropriate for the regulatory authority to open it up limitedly and present guidelines?"Director Lee Jae Hyuk of the Korea Regulatory Affairs Professionals Society also suggested that we should contemplate expanding medical options in the selection of medications for pediatric patients.The suggestion is that although the question of how to manage habitual and addictive drugs is a long-standing proposition for humanity, there is a great necessity to allow their use for medical or academic purposes.Lee said, "Even if production or distribution is strictly controlled, use should not be restricted as much as possible if medical necessity is recognized," and "Regardless of how the issue of abuse is managed as a separate focus, it is not a solution for abuse countermeasures to simply prohibit use unconditionally. A prescription environment where it can be used reasonably must be established.""No issues with pediatric patients using the phentermine combination if the treatment purpose is clear"Jeong Hyeon-cheol, Director of the Narcotics Policy Division at the MFDS, who participated as a panelist, stated that even now, there is no problem with prescribing the phentermine combination for pediatric patients where the necessity for administration is clear, such as those in high-risk groups for adult-onset diseases.This suggests that the MFDS has a sufficient range of understanding regarding the physician's right to prescribe for treatment purposes, and that simply expanding the administration indication for pediatric patients is difficult to view as the only solution.Jeong emphasized, "Regarding the facts, pediatric patients for whom use is essential due to the urgency of disease treatment risks can essentially be seen as not being restricted by prescription regulations," and "However, an inconvenient situation where a doctor has to provide a justification after prescribing may occur. This is because we operate a pre-notice system for the abuse of narcotics."Jeong highlighted, "For example, we request 4,500 doctors identified over a year as having exceeded the action standards for narcotic abuse to explain their reasons for prescription; afterward, through a committee of experts composed of doctors and pharmacists, we verify if the justification is valid, and the number decreases to units of hundreds or tens," and "The MFDS cannot restrict the physician's right to prescribe. It may be inconvenient, but the MFDS is allowing the prescription of phentermine combinations for pediatric patients."Jeong added, "To explain the questions the general public might have regarding the phentermine combination, the MFDS has approval standards, and the insurance authorities have reimbursement standards. The standards inevitably differ for each," and "After listening to the healthcare professionals, there is a need to allow its use for pediatric patients with metabolic syndrome, but the fundamental administrative goal is to prevent the abuse of psychotropic narcotics. If clinical data is submitted, we will review it."Jeong Hyeon-cheol, Director of the Narcotics Policy Division at the MFDS (left), Professor Jae-Hyuk Lee Professor Jae-Hyuk Lee of the Department of Endocrinology at Myongji Hospital (Director of the General Affairs Committee of the KSSO), who served as the chairperson, expressed concern that the method of 'justification after prescription' has significant irrational aspects and may hinder active treatment.Professor Lee emphasized, "The method of letting it pass if a proper exception is justified is not easy in clinical practice. Doctors try to avoid the task of justifying prescriptions that exceed regulations, which makes treatment difficult from the start," and "If the Ministry writes the prescription indication regulations well, healthcare professionals can accept prescribing according to those regulations."Professor Lee suggested, "If the regulations are excessively broad as they are now, it is difficult to use the drug (for pediatric patients) and post-monitoring regulation becomes complicated," and "It is ideal to manage the administration indications well and strictly regulate those that are exceeded. There are difficulties with the current method of 'do not use for now, but if you did, justify it and if that is correct, we will allow it.' Why not create the prescription regulations well so that doctors can use them properly?"
- Policy
- Generic Tagrisso and Xtandi approved in Korea
- by Lee, Tak-Sun Jan 29, 2026 08:16am
- Chong Kun Dang and Menarini have each received approval for generic versions of the oncology drugs Tagrisso and Xtandi, respectively.Particularly noteworthy is Chong Kun Dang's success in becoming the first in Korea to commercialize a generic version of Tagrisso, raising attention as to whether this will translate into early market entry.On the 27th, the Ministry of Food and Drug Safety approved two dosage strengths of Chong Kun Dang’s ‘Otinib Tab’ as well as Menarini Korea’s ‘Enzalex Soft Cap 40 mg.’CKD’s Otinib is the first approved generic version of osimertinib in Korea. The original product containing osimertinib is AstraZeneca’s Tagrisso.Both Tagrisso and Otinib are indicated for patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.Tagrisso recorded KRW 111 billion in domestic sales in 2023 (IQVIA data). Yuhan’s Leclaza (lazertinib) is its key competing product. Given its high commercial value, multiple later entrants are seeking early access to the market.CKD has taken on the challenge to circumvent Tagrisso’s formulation patent, which is scheduled to expire in January 2035. Avoiding this patent would allow market entry in 2033, when Tagrisso’s compound patent expires. Kwangdong Pharmaceutical is also attempting the same patent challenge.Although Otinib has now received regulatory approval, active market launch is not yet possible due to the remaining compound patent.Nevertheless, analysts suggest that securing a priority marketing approval (generic exclusivity) to capture the generic market first could lead to high sales.Menarini’s Enzalex Soft Cap contains enzalutamide as the active ingredient. The originator product is Astellas’ Xtandi and is used to treat prostate cancer. Xtandi recorded KRW 43.2 billion in domestic sales in 2023, according to IQVIA.This is not the first approval of an Xtandi generic in Korea. Last year, Alvogen Korea and Daewon Pharm received approvals for Anadin Soft Cap and Enzadex Soft Cap, respectively. Earlier this month, HanAll Biopharma also succeeded in listing its enzalutamide generic, Enzaluta Soft Cap, on the MFDS approval registry.With Xtandi’s compound patent set to expire in June, the opening of its generic market later this year is considered a strong possibility.However, a key variable remains the formulation patent for enzalutamide, which is scheduled to expire in September 2033. Generic manufacturers have filed patent invalidation or circumvention actions targeting this formulation patent. Whether they succeed in avoiding the patent will determine if launches occur within the year.
- Company
- First FRα-targeted ADC Elahere approved for ovarian cancer
- by Son, Hyung Min Jan 29, 2026 08:16am
- The antibody–drug conjugate (ADC) class has entered the ovarian cancer field, signaling a potential shift in the treatment paradigm.On the 28th, AbbVie Korea held a press briefing at the Plaza Hotel in Jung-gu, Seoul, to mark the approval of Elahere (mirvetuximab soravtansine) in Korea.Elahere was approved last month for the treatment of high-grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is folate receptor alpha (FRα) positive and resistant to platinum-based chemotherapy, in patients who have previously received one to three prior systemic therapies before the 19th of last month.Jung-yun Lee, Professor of Obstetrics and Gynecology, Severance HospitalElahere is an ADC targeting FRα-positive ovarian cancer. Its mechanism involves delivering the potent cytotoxic drug DM4 directly into cancer cells to destroy the tumor. The drug is drawing particular attention as a new option for patients with ovarian cancer who have developed resistance to platinum-based chemotherapy.Patients with platinum-resistant ovarian cancer often have compromised systemic health due to cumulative toxicity from repeated prior treatments and comorbidities. Therefore, effective later-line treatment options are crucial. However, existing standard treatments like non-platinum-based chemotherapy or certain targeted therapies have shown limited clinical benefits, with low response rates and no statistically significant improvement in survival.In clinical studies, Elahere reduced the risk of disease progression or death by 35% compared with standard non-platinum chemotherapy.The median progression-free survival (PFS) was 5.62 months, an improvement over 3.98 months in the control group. The objective response rate (ORR) reached up to 42.3%, significantly higher than 15.9% observed with standard therapy. The median overall survival (OS) was 16.85 months, versus 13.34 months in the control group, corresponding to a 32% reduction in the risk of death.From a safety perspective, the majority (88%) of adverse events observed in the Elahere treatment group were low-grade and manageable.The Korean Society of Gynecologic Oncology (KSGO) guidelines recommend Elahere for the treatment of FRα-positive platinum-resistant ovarian cancer with the highest level of evidence (Level I) and strongest recommendation grade (Grade A).Jung-yun Lee, Professor of Obstetrics and Gynecology, Severance Hospital, who participated in the pivotal clinical trial, stated, “Elahere demonstrated meaningful improvements across key clinical endpoints in platinum-resistant ovarian cancer, an area with high unmet medical need. It also showed consistent efficacy across subgroups. With an ORR of 42.3%, which is higher than that of the control group, Elahere offers the possibility of improved outcomes even for patients who previously had limited expectations of response. It is the first FRα-targeted therapy to demonstrate an overall survival benefit.”Importance of biomarker testing rises in ovarian cancerProfessor Jae-kwan Lee, Korea University Guro Hospital, Department of Obstetrics and GynecologyWith the approval of Elahere, biomarker-driven personalized treatment strategies are now being more fully implemented in ovarian cancer, raising expectations for meaningful changes in the treatment paradigm.While targeted therapies in ovarian cancer were previously limited to those based on the expression of a few biomarkers like PARP and HER2, the emergence of Elahere has highlighted the importance of FRα biomarker testing.FRα is a protein involved in tumorigenesis and is minimally expressed in normal tissues but highly expressed in ovarian cancer.Approximately 35-40% of all ovarian cancer patients are reported to be FRα-positive. Its expression tends to remain consistent from diagnosis through recurrence, enabling personalized targeted therapy when the cancer progresses to platinum-resistant ovarian cancer.This biomarker is determined positive when membrane staining intensity of 2+ or higher is confirmed in at least 75% of tumor cells using Roche Diagnostics' immunohistochemistry (IHC)-based companion diagnostic assay.Professor Jae-kwan Lee of the Department of Obstetrics and Gynecology at Korea University Guro Hospital said, “Depending on tumor heterogeneity, even cases previously negative for FRα may become positive upon recurrence. For patients without treatment alternatives, retesting should be considered.”
- Policy
- KSPST 'Generic drug price cuts not right for fiscal savings'
- by Lee, Tak-Sun Jan 29, 2026 08:16am
- Cheong-won Cho, the newly appointed president of the Korean Society of Pharmaceutical Science and Technology (KSPST), expressed a critical view of the government’s policy to lower generic drug prices, stating that such an approach is not logically consistent if the objective is to reduce National Health Insurance (NHI) spending. She argued that to reduce NHIS spending, the use of generic drugs should be promoted rather than cutting their price.Cho made the remarks during a press briefing held on the 28th at a restaurant in Yeoksam-dong, Seoul. “Given concerns about the depletion of the NHI fund, policies aimed at narrowing financial gaps are necessary. However, lowering generic drug prices as a means of reducing NHI expenditure seems illogical.”“Lowering generic drug prices would have a devastating impact on pharmaceutical companies' profits, leading to workforce reductions and decreased R&D investment. The government claims that lowering generic drug prices will encourage increased investment in new drug development, but I believe the government and the pharmaceutical industry are heading in different directions on this point.”“It's not that the government's position is wrong, but rather than focusing on lowering generic drug prices, they should seek various methods to prevent the depletion of the national health insurance fund. I think it would be good if the government held a close ear to the input from relevant academic circles and organizations and considered the overall situation to restructure the system based on a predictable scenario.” President Cho explained that activation of generics following patent expiration of originator drugs is, in itself, beneficial to NHI finances.This was Cho's first meeting with the press after being appointed President of KSPST. Currently a professor at Chungnam National University College of Pharmacy, she expressed her ambition for strengthening the society’s internal capabilities while expanding its external influence.Cho said, “As pharmaceutics advances, regulatory environments are becoming more complex and global competition more intense. We will establish a robust academic framework and build effective R&D programs. To expand our reach, we will form consortia with domestic and international academic societies and foreign journals, and establish a systematic framework to support the society's sustained growth.”The newly appointed executive board of the Korean Society of Pharmaceutical Science and Technology poses for a commemorative photo after concluding a press conference on the 28th. (From left: Scientific Program Committee Chair Jin-wook Yoo, General Affairs Committee Chair Sangkil Lee, President Cheong-won Cho, Secretary General Yu Seok Yoon, Public Relations Committee Chair Jun-Bom Park)Yu Seok Yoon, Secretary General of KSPST, who also attended the event, said, “The society must serve as a bridge between basic science and clinical practice. We will continue to expand into areas where social and academic demand exists.”Founded in 1971, KSPST is a reputable academic organization that has dedicated 54 years to advancing pharmaceutical research and scholarship. It has approximately 1,200 members and has contributed to the development of the pharmaceutical industry and the promotion of public health through the dissemination of pharmaceutical R&D achievements and industry collaboration.Last year, the society shared the latest developments in pharmaceutics through the Formulation Technology Workshop and an International Academic Conference. The Formulation Technology Workshop drew participation from approximately 500 experts from industry, academia, and research institutes. Its International Academic Conference also gathered over 650 attendees, including 36 domestic and international speakers from 11 countries, marking its largest-ever participation.This year’s major events include a Science Month symposium on April 10, a Formulation Technology Workshop on September 18, and the Society’s General Assembly and International Conference from November 25 to 27.Jin-wook Yoo, Chair of the Scientific Program Committee, noted, “Through our academic conferences, we aim to strengthen industry-academia-research collaboration by pursuing both academic depth and industrial applicability. We plan to establish an academic foundation for the pharmaceutical-biotech sector's leap forward and organize conference sections reflecting the latest technological trends.”
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- 'Ozempic' prescriptions available at general hospitals
- by Eo, Yun-Ho Jan 28, 2026 08:12am
- Product photo of Ozempic'Ozempic,' the diabetes treatment containing the same active ingredient as the obesity drug Wegovy, is entering the general hospital prescription areas.According to industry sources, Novo Nordisk Korea's GLP-1 receptor agonist (GLP-1 RA) Ozempic has passed the drug committees (DC) of major tertiary general hospitals, including Samsung Medical Center and Seoul National University Hospital. Ozempic is currently securing its prescription area ahead of the implementation of insurance reimbursement in February.Ozempic, which will be listed next month, can be prescribed as part of a triple therapy including metformin and sulfonylurea (SU), or in combination with insulin. However, unlike existing GLP-1 analogs, the reimbursement criteria have been restricted to 'Type 2 diabetes patients whose glycated hemoglobin (HbA1C) levels remain at 7% or higher despite at least 2 to 4 months of combination drug therapy.'While analysis suggests that this is Ministry of Health and Welfare's measure to prevent misuse or abuse of Ozempic, some critics argue it limits patient access. It remains to be seen how much Ozempic, with many limitations, will demonstrate in the diabetes treatment market.Competition within the GLP-1 class is expected to intensify further, as Eli Lilly Korea’s GIP/GLP-1 dual receptor agonist 'Mounjaro (tirzepatide)' is also currently undergoing price negotiations with the National Health Insurance Service (NHIS) for diabetes reimbursement listing.Meanwhile, Ozempic demonstrated powerful blood sugar-lowering and weight loss effects compared to various diabetes medications, including DPP-4 inhibitor Januvia (sitagliptin), the exendin-4-based GLP-1 RA Byetta (exenatide), and the GLP-1 RA Trulicity (dulaglutide), through six Phase 3 studies (SUSTAIN 1–5 and 7). Notably, Ozempic showed superior blood sugar-lowering effects compared to insulin while maintaining a lower risk of hypoglycemia.The 'SUSTAIN 9' study confirmed additional blood sugar and weight reduction effects in Type 2 diabetes patients who did not achieve sufficient control following treatment with SGLT-2 inhibitors, a leading class of oral diabetes medications. In the 'SUSTAIN 6' Phase 3 trial, the drug reduced the risk of major adverse cardiovascular events (MACE) by 26% in adult patients with Type 2 diabetes and high cardiovascular risk.
