規制動向
2026年9月21日•1分で読めます
Regulatory Shift Reduces Comparative Clinical Trials in Biosimilar Development
Large-scale comparative clinical efficacy studies are being scaled back, with global regulators emphasizing advanced quality analysis and PK data, according to a KoBIA report.
規制動向
2026年9月2日•1分で読めます
FDA approves five new products in June, spanning cell therapy to biosimilars
The FDA granted approvals for five products in June—including a cell therapy, rare‑disease drug, antibiotic, imaging contrast agent and a biosimilar—signaling trends in advanced biopharma.
規制動向
2026年8月30日•1分で読めます
Korean Biotech Firms Rank Second Globally in FDA Biosimilar Approvals
Korean companies have secured 19 of the 87 FDA‑approved biosimilars through June 2026, placing Korea second worldwide after the United States.
規制動向
2026年8月23日•1分で読めます
PMDA Updates Information on Biosimilars
The Pharmaceuticals and Medical Devices Agency (PMDA) has updated its biosimilars information. Details are available on the PMDA website.