法规动态
2026年9月21日•1 分钟阅读
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.
法规动态
2026年9月2日•1 分钟阅读
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.
法规动态
2026年8月30日•1 分钟阅读
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.
法规动态
2026年8月23日•1 分钟阅读
PMDA Updates Information on Biosimilars
The Pharmaceuticals and Medical Devices Agency (PMDA) has updated its biosimilars information. Details are available on the PMDA website.