- Policy
- NA starts Special Act to support the pharma and bio industry
- by Lee, Jeong-Hwan Feb 27, 2025 05:56am
- The National Assembly is pushing for the enactment of a special law to bring together the capabilities at the national level to promote and foster the biopharmaceutical industry. The policy agenda includes the establishment of a basic plan every 5 years, the establishment of a Pharmaceutical Biohealth Innovation Committee, and the provis
- Policy
- Priority mkt authorization for Trajenta generics ends
- by Lee, Tak-Sun Feb 25, 2025 05:57am
- As the priority marketing authorization for the generic version of Trajenta (linagliptin), a DPP-4 inhibitor used to treat diabetes, launched last year will end on March 8, generics that have been waiting for 10 months will be launched. The list of generics to be launched includes Hanmi Pharmaceutical and Genuone Sciences. According to
- Policy
- Only Rinvoq to undergo drug pricing reduction
- by Lee, Tak-Sun Feb 25, 2025 05:57am
- As the reimbursement of drug switching between biological agents and JAK inhibitors for the treatment of severe atopic dermatitis will be implemented next month, additional claim amounts are reported to be insignificant. Rinvoq ER Tab (AbbVie, upadacitinib) is the only product to see drug pricing reduction due to the expected additional
- Policy
- Generic drugs enter KRW 150 billion Prolia market
- by Lee, Tak-Sun Feb 25, 2025 05:57am
- A competitor to Prolia (Amgen, co-marketed by Chong Kun Dang), which has dominated the market for osteoporosis treatment with its convenience and efficacy, will be released next month. Celltrion will make the launch. Celltrion plans to launch its biosimilar after the expiration of the Prolia product patent on the 17th of next month. Ac
- Policy
- PMS of Rekovelle shows ovarian hyperstimulation
- by Lee, Hye-Kyung Feb 21, 2025 05:56am
- The reevaluation of Ferring Korea’s fertility drug ‘Rekovelle Prefilled Pen (follitropin delta)’ revealed that 0.65% of patients experienced ovarian hyperstimulation syndrome, which is expected to be added as an adverse event. The Ministry of Food and Drug Safety announced on the 20th the proposed changes to the licensed conditions fol
- Policy
- Ocrevus, DM Duo reimbursed from March
- by Lee, Jeong-Hwan Feb 21, 2025 05:56am
- Roche's new multiple sclerosis drug Ocrevus (ocrelizumab) and Hyundai Pharm’s first dementia combination drug DM Duo (donepezil + memantine) will be reimbursed by Korea’s national health insurance starting next month. Amgen's osteoporosis drug Prolia will see some changes to its reimbursement standard as Celltrion's biosimilar Stoboclo
- Policy
- 'JAK inh-biological agent' switching will be reimb in March
- by Lee, Jeong-Hwan Feb 21, 2025 05:56am
- The National Health Insurance reimbursement standard for severe atopic dermatitis treatments will be extended starting March 1. The key change is reimbursement coverage for switching between JAK inhibitor and biological agent. The Ministry of Health and Welfare (MOHW) announced on February 20 that it gave administrative notice of 'Partial
- Policy
- Pfizer 'Vyndamax' reimbursed from March…KRW 100,000/cap
- by Lee, Tak-Sun Feb 21, 2025 05:56am
- About 20% of the non-reimbursed price…significantly reduces patient with a special exemption of calculation provisions The completion of negotiations with the National Health Insurance Service (NHIS) has been reported, so the reimbursement listing was a matter of time. The ceiling price is reported to be KRW 100,000 per capsule. Accor
- Policy
- Dilemmas for fostering pharma and lowering drug prices
- by Lee, Tak-Sun Feb 19, 2025 05:56am
- What would be a reasonable drug pricing policy to foster new drug development? The government is focusing on the sustainability of the National Health Insurance, while the industry expresses concerns about decreasing new drug development due to reduced drug prices. These conflicting perspectives are raising about the future direction of drug pri
- Policy
- Boehringer Ingelheim, HIRA enter drug price negotiations
- by Lee, Tak-Sun Feb 19, 2025 05:56am
- As for reimbursement listing of 'Ofev (nintedanib),' a treatment for idiopathic pulmonary fibrosis (IPF), domestic distributor Boehringer Ingelheim and the Health Insurance Review and Assessment Service (HIRA) have entered drug price negotiations. Since the substance patent of Ofev expired last month, generic companies have already obtain
