- Policy
- Yungjin, Ildong’s Ofev generics enter market at half price
- by Lee, Tak-Sun Jun 26, 2025 06:07am
- A generic version of Ofev (nintedanib), a treatment for chronic fibrotic interstitial lung disease), will enter the market at half the price of the original drug. With the entry of generic drugs, the Ofev market now faces competition, just two months after the original drug was listed for reimbursement. According to industry sources o
- Policy
- Daewoong's high-dose generic 'Xeljanz' wins nod
- by Lee, Hye-Kyung Jun 26, 2025 06:06am
- Daewoong Pharmaceutical's oral generic version of 'Xeljanz (tofacitinib),' which is used to treat rheumatoid arthritis, received approval. On June 23, the Ministry of Food and Drug Safety (MFDS) approved Daewoong Pharmaceutical's two dosages of 'Xeltofa Tab': 5 mg and 10 mg. The latest approval grabs attention, particularly because Dae
- Policy
- Samsung Bioepis joins Prolia market with Obodence
- by Lee, Tak-Sun Jun 25, 2025 06:02am
- With Samsung Bioepis entering the biosimilar market for Prolia (denosumab), competition is expected to intensify among co-promoter companies Daewoong Pharmaceutical (Stoboclo, Celltrion), Hanmi Pharmaceutical (Obodence, Samsung Bioepis), and Chong Kun Dang (original Prolia, Amgen). Chong Kun Dang signed a co-promotion agreement with the origi
- Policy
- Inspections target faulty packaging·labeling of drugs
- by Lee, Jeong-Hwan Jun 24, 2025 06:00am
- The Korean government and local governments will launch inspections targeting pharmaceutical companies with a history of recalls due to faulty packaging or labeling of medicinal products and illegal advertising of GLP-1 obesity drugs, such as Wegovy. For GLP-1 obesity drugs, to prevent misuse and abuse, inspections will focus on handling
- Policy
- Industry expects improved pricing measures by new gov't
- by Lee, Jeong-Hwan Jun 23, 2025 06:01am
- The domestic pharmaceutical industry is closely monitoring the direction of the Lee Jae-Myung administration's preferential drug pricing policy. The industry is most interested in when and how the presidential election pledges, including specific implementation plans for the new drug R&D-linked preferential drug pricing policy and the in
- Policy
- Generic 'Lixiana' is now in 'active' development in KOR
- by Lee, Hye-Kyung Jun 23, 2025 06:01am
- Korean pharmaceutical companies are actively working on plans to launch their generic version of 'Lixiana Tab 60 mg (edoxaban tosylate hydrate),' a Direct Oral Anti-Coagulant (DOAC) with patent expiry set to November of next year. The Ministry of Food and Drug Safety (MFDS) recently approved Korean Drug Co's application for a bioequivalenc
- Policy
- Handok and JW’s new imported drugs reimbursed from July
- by Lee, Tak-Sun Jun 23, 2025 06:00am
- In July, four new drugs, including an oral drug for paroxysmal nocturnal hemoglobinuria (PNH), a new biological agent for severe atopic dermatitis, and a new drug for immune thrombocytopenia (ITP), will be reimbursed by health insurance and be available with coverage for patients. On the 19th, the MOHW announced the establishment of reim
- Policy
- Rapid adjustment of insurance prices for rare drugs granted
- by Lee, Hye-Kyung Jun 20, 2025 06:08am
- The insurance price ceiling adjustment term for insured drugs supplied by the Korea Orphan Drug Center (KOEDC) is expected to be significantly reduced from the initial 8-9 months to around 4 months. Previously, it took at least 8-9 months to adjust the price cap, raising concerns about supply disruptions and financial losses for the cente
- Policy
- SGLT2 Jardiance likely to receive expanded reimb for CKD
- by Lee, Tak-Sun Jun 20, 2025 06:06am
- The SGLT-2 inhibitor Jardiance (empagliflozin, Boehringer Ingelheim) is expected to be reimbursed for the treatment of chronic kidney disease (CKD). This drug is currently reimbursed for the treatment of diabetes and chronic heart failure. If expanded reimbursement is approved for CKD, the volume of usage is likely to be increased. Further
- Policy
- Growing role of the Korea Orphan & Essential Drug Center
- by Lee, Hye-Kyung Jun 19, 2025 06:03am
- "The emergency import of essential medicines through the Korea Orphan & Essential Drug Center (KOEDC) will be expanded, and support for pharmaceutical companies producing domestic products will be planned." President Lee Jae-myung made this pledge on his Facebook page on May 28, during his campaign for the presidency. President Lee emphasized
