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- 2026-03-09 22:16:18
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- Policy
- Adstiladrin receives expedited review in Korea
- by Lee, Tak-Sun Mar 09, 2026 08:53am
- The gene therapy for bladder cancer ‘Adstiladrin,’ developed by Swiss company Ferring Pharmaceuticals, has been selected for Korea’s GIFT program, enabling expedited regulatory review by the Ministry of Food and Drug Safety (MFDS).The drug is the world’s first gene therapy for bladder cancer and received U.S. FDA approval in 2022.The MFDS announced on the 6th that Adstiladrin (nadofaragene firadenovec) has been designated as a drug eligible for fast-track review. The designation date was February 4th.The therapy has been submitted for approval in Korea for the treatment of high-risk non–muscle-invasive bladder cancer (NMIBC) that is Bacillus Calmette-Guerin (BCG)-unresponsive with carcinoma in situ (CIS), with or without papillary tumors.The MFDS designated the drug for fast-track review, citing improved efficacy compared with existing treatments. It had previously also been designated as an orphan drug.Adstiladrin also underwent fast-track review during the U.S. FDA approval process, leading to its accelerated approval. The therapy exerts its antitumor effect through the expression of the interferon alpha-2b (IFNα2b) gene delivered via a non-replicating adenovirus vector, administered intravesically.The GIFT program is a Global Innovative products Fast-Track Review Program designed to support the development of innovative medical products in Korea and has been in operation since September 2022.Eligible products include innovative medicines targeting life-threatening diseases, rare diseases with no existing treatment alternatives, and new drugs developed by certified Korea Innovative Pharmaceutical Companies.The MFDS conducts a comprehensive evaluation of the candidates’ innovative therapeutic benefits, contributions to addressing public health crises, and the developer’s efforts, among other factors.Adstiladrin has been designated as GIFT No. 65. Among the 50 products approved under the GIFT program so far, 42 are orphan drugs.
- Policy
- Health and Welfare Committee to conduct inquiries on pending issues next week
- by Lee, Jeong-Hwan Mar 09, 2026 08:53am
- The ruling and opposition party leaders of the National Assembly's Health and Welfare Committee have agreed to hold a plenary session on the 10th of next week to receive this year's (2026) business reports and conduct inquiries on pending issues.The committee plans to hold the First and Second Subcommittees for Legislations on the 11th and 12th, respectively, to process pending legislation. Following this, the bills are expected to be approved during a plenary session on the 13th and forwarded to the Legislation and Judiciary Committee.Key issues to be highlighted during next week's plenary session include the findings regarding contaminated COVID-19 vaccines and the proposed restructuring of the drug pricing system, which includes price cuts for generics and preferential pricing for innovative pharmaceuticals.Other pressing topics include policies to strengthen regional, essential, and public healthcare, such as increasing medical school quotas, establishing new regional·public medical schools, and implementing a regional physician system.The opposition, led by the People Power Party, is expected to take issue with Minister of Health and Welfare Jung Eun Kyeong's failure to publicly announce cases of COVID-19 vaccines containing mold or foreign substances during her previous leadership as Commissioner of the Korea Disease Control and Prevention Agency (KDCA). They are likely to demand a parliamentary investigation.Rep. Kim Mi-ae, the executive secretary of the committee, along with Rep. Na Kyung-won and Rep. Shin Dong-wook, are strongly calling for Minister Jung’s immediate resignation. They are also demanding that the government drop its appeals against vaccine-related lawsuits and initiate a parliamentary investigation into the contaminated vaccines.Lawmakers from the Democratic Party also plan to question the announcement regarding the contaminated vaccine issue during next week's session. As the majority party, they are expected to counter the opposition's criticisms by emphasizing the necessity of vaccinations during the peak of the COVID-19 pandemic.Regarding the drug pricing restructuring, which the Ministry of Health and Welfare (MOHW) plans to implement in July following approval by the Health Insurance Policy Deliberation Committee this month, inquiries are expected to focus on whether the system adequately encourages and fosters innovation within the domestic pharmaceutical and biotech industry.In fact, Rep. Kim Yoon of the Democratic Party previously criticized the MOHW's plan as "too mechanical" and insufficient for rewarding the innovativeness of domestic pharmaceutical companies, and subsequently demanded the submission of a revised proposal.Despite persistent protests from the Korean pharmaceutical industry against the restructuring plan, the MOHW is maintaining its position in its policy to secure Health Insurance Policy Deliberation Committee approval in March.The MOHW plans to hold a one-point subcommittee meeting on the drug pricing restructure next week, followed by a final vote at the plenary session at the end of the month. Detailed calculation rates for generic drugs and preferential pricing measures for innovative pharmaceutical companies are expected to be finalized within this month.The MOHW has proposed reducing the generic pricing rate from the current 53.55% to the 40%, while the pharmaceutical industry views 48% as their bottom line or maximum acceptable cut.Furthermore, the industry argues that the criteria and mechanisms for preferential pricing must be significantly revised to reflect contributions to the development of the domestic industry and to the manufacturing, production, and distribution of high-quality medicines, in order to achieve the Ministry's policy goals.An official from a Health and Welfare Committee member’s office commented, "Since the New Year's business reports have been delayed and the bill subcommittees have not met properly for months, holding the standing committee in March is essential," adding , "The People Power Party has agreed to participate, and I understand that pending issues like the COVID-19 vaccine contamination played a role in that decision."
- Policy
- GSK’s Nucala-Omjjara enters pricing negotiations for reimb in Korea
- by Jung, Heung-Jun Mar 09, 2026 08:53am
- [GSK Korea’s new myelofibrosis drug Omjjara (momelotinib) and the eosinophilic disease treatment Nucala Autoinjector (mepolizumab) have entered drug price negotiations with the National Health Insurance Service (NHIS).In addition, Janssen Korea’s new multiple myeloma treatment, Darzalex SC injection (daratumumab), is also proceeding with price negotiations, the final stage of reimbursement listing.According to industry sources on the 6th, new drugs that passed the Drug Reimbursement Evaluation Committee (DREC) in January have entered the negotiation process with the NHIS.Both Omjjara and Nucala passed the DREC with the condition that reimbursement would be accepted only if the price is set below the committee’s evaluation amount. AI-generated imageOmjjara Tab (100, 150, and 200 mg) was deemed adequate for reimbursement as a treatment for intermediate- or high-risk myelofibrosis in adults with anemia. Nucala Inj was deemed adequate for reimbursement as an add-on maintenance therapy for the treatment of severe eosinophilic asthma in adults and adolescents that is inadequately controlled with existing treatments.With GSK receiving reimbursement approval for two new drugs simultaneously, expectations are rising on the possibility of their concurrent listing.Omjjara passed the Cancer Disease Deliberation Committee review last March but faced delays in reaching the DREC due to issues such as the selection of comparator drugs, requiring a resubmission. It cleared the DREC hurdle approximately 10 months after resubmission.Meanwhile, the Nucala Autoinjector, a new formulation of the drug, is a self-injectable device that allows patients to administer the treatment at home. If reimbursement coverage is expanded to include the self-injection formulation, Nucala’s prescription market presence is expected to grow.At the previous DREC meeting, both Omjjara and Nucala were approved with the condition that reimbursement is appropriate only if the company accepts a price below the evaluated amount. Since the pharmaceutical company has accepted this condition, negotiations with the NHIS are expected to focus on details such as the projected claims amount.Meanwhile, Janssen Korea’s Darzalex SC Inj was recognized as appropriate for reimbursement for ‘combination therapy with bortezomib, cyclophosphamide, and dexamethasone in newly diagnosed light-chain amyloidosis patients.’Unlike Omjjara and Nucala, Darzalex did not receive the “below evaluation price” condition from DREC, allowing it to proceed directly to price negotiations.Following its approval by the CDDC in the latter half of last year, the subcutaneous injection formulation of Darzalex is steadily gaining access to tertiary hospitals in Korea.
- Company
- PAH drug Winrevair may be prescribed at general hospitals in Korea
- by Eo, Yun-Ho Mar 09, 2026 08:53am
- The new pulmonary arterial hypertension (PAH) drug Winrevair is beginning to gain prescribing access at major hospitals in Korea.According to industry sources, MSD Korea’s activin signaling inhibitor (ASI) Winrevair (sotatercept has passed the drug committee (DC) reviews at leading tertiary hospitals, including Samsung Medical Center and Seoul National University Hospital.At the same time, MSD is currently conducting landing procedures at about 20 major medical institutions nationwide.Winrevair is a first-in-class innovative drug with a new mechanism of action, emerging 20 years after sildenafil, which targets the NO–sGC–cGMP pathway, was introduced in 2005. The drug is currently selected for the second phase of Korea’s ‘Approval-Evaluation-Negotiation Concurrent Pilot Program’ and is undergoing reimbursement procedures, but no significant progress has been made so far.Pulmonary arterial hypertension is a particularly challenging area for new drug development. Unlike existing treatments focused on dilating blood vessels, Winrevair improves vascular remodeling, the fundamental cause of the disease.Consequently, no comparable therapeutic alternative is available. If Winrevair is evaluated within the existing economic assessment framework, it would be compared to treatments developed two decades ago. This situation naturally delays the listing process. This challenge is not unique to Winrevair but is one commonly faced by drugs included in the parallel pilot program. Nearly 200 days have already passed since Winrevair received approval from Korea’s Ministry of Food and Drug Safety.Therefore, attention is now focused on whether Winrevair will successfully complete the reimbursement listing process and ultimately establish itself as a treatment option for patients.Winrevair received regulatory approval based on the STELLAR clinical trial. This study evaluated the efficacy and safety of Winrevair in 323 adult patients with pulmonary arterial hypertension (PAH) classified as WHO functional class (WHO-FC) II or III. During the 24-week study period, patients received Winrevair or a placebo in combination with their existing therapy once every three weeks.Results showed that Winrevair increased the 6-minute walk distance by 40.8 meters (Hodges–Lehmann estimate) compared with placebo at Week 24. It also reduced the risk of clinical worsening or death by 84%.In addition, significant improvements were observed across 8 secondary endpoints, including WHO-FC, pulmonary vascular resistance (PVR), and the heart failure biomarker NT-proBNP, compared with placebo.Wook Jin Jeong, President of the Korean Society of Pulmonary Hypertension (Professor of Cardiology at Gachon University Gil Medical Center), said, “Winrevair is a treatment with a new mechanism of action that restores abnormal pulmonary vascular structure toward normal. Based on the latest evidence, updated global clinical guidelines now present it as an option for combination therapy in the early phases of treatment. This approval broadens the treatment options available to pulmonary arterial hypertension patients in Korea.”
- Company
- Pharma labor groups voice "job security concerns" ahead of drug pricing reform
- by Kim, Jin-Gu Mar 06, 2026 08:44am
- Gemini 생성 이미지.As the government's drug pricing reform plan is soon to be finalized, labor groups in the pharmaceutical industry visited the Blue House (Presidential Office) to voice concerns regarding the policy's potential impact on employment.According to pharmaceutical industry sources on the 5th, the Pharmaceutical and Cosmetics Division of the Federation of Korean Chemical Workers' Unions (FKCU), under the Federation of Korean Trade Unions (FKTU), recently hosted a meeting with the Secretary to the President for Health and Welfare and the Secretary for Labor at the Presidential Office. The meeting was attended by Jang-hoon Lee, Chairman of the Pharmaceutical and Cosmetics Division, along with members of the FKTU's External Cooperation Headquarters.During a phone call with DailyPharm, Chairman Lee stated, "Organized by the FKTU, we met with the Secretary to the President for Health and Welfare and for Labor. We delivered our opinions on the drug price reductions from the perspective of workers." "We expressed concerns that if the government forces through the drug price reductions, it will undermine job security and hurt job creation," he said, "Regarding this, the Presidential Office responded that they could not provide a definitive answer at this time."The drug pricing reform plan was originally scheduled to be finalized through a resolution of the Health Insurance Policy Deliberation Committee last month; however, the schedule was postponed once due to continued backlash from the pharmaceutical and labor sectors. The government plans to hold a meeting in March to finalize the proposal, which includes the calculation rate for reductions in generic drug prices. Within the industry, a schedule is being discussed to pass the plan through the subcommittee on the 11th and reach a resolution at the plenary session in mid-March.Labor groups maintain that the government must consider the impact on industry and employment as it finalizes the reform plan. However, as specific details of the reform have not been disclosed, they plan to determine the intensity of their response after monitoring the HIPDC's discussion process.Regarding this, pharmaceutical labor unions under the FKCU will hold a two-day resolution rally starting on the 10th to fight for victory in the 2026 wage and collective bargaining agreements. Their response to the drug pricing reform is also expected to be discussed at this meeting.Chairman Lee stated, "Although this meeting is intended for the 2026 wage negotiations, discussing the direction of the union's response will be a major topic because concerns regarding the drug price reductions are great. Chairmen of the FKTU and the FKCU are also scheduled to attend, and we will review countermeasures together."The possibility of a joint response with the pharmaceutical and biotech industry has also been raised. Chairman Lee added, "I understand that the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) is also discussing countermeasures," adding, "It is reported that various methods, such as a national signature campaign or a public petition, are being considered. We are exploring ways to respond jointly with the Association."On January 29, the FKTU issued a statement opposing the government's drug pricing reform, stating, "A hasty reform that excludes workers can protect neither the health insurance finances nor the pharmaceutical industry."At the time, the FKTU criticized, "We express deep concern that the drug pricing reform currently pursued by the government is being unilaterally pushed forward without sufficient social discussion and agreement," adding, "Indiscriminate drug price reductions are highly likely to eventually lead to a deterioration of labor conditions and layoffs. Policies that threaten the survival rights of workers will, in the long term, undermine the public's access to medicines and right to health.""As an organization representing National Health Insurance subscribers, we cannot tolerate policy decisions made through closed-door and desk-bound administration while excluding workers, patients, and the public," adding, "The government must transparently disclose the basis and financial effects of the drug pricing reform and immediately establish a social discussion structure where the opinions of stakeholders are substantially reflected."The FKTU concluded, "We will fulfill our responsible role to ensure that the interests of health insurance subscribers and the survival rights of workers are harmoniously reflected in the future drug pricing reform discussion process," adding, "We clearly state that we will never slip any attempts to cause a retreat in labor conditions or job insecurity under the disguise of this policy."
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