Requirements for Phase 3 Biosimilar Clinical Trials to Be Eased… Industry Revitalization Promoted

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The Ministry of Food and Drug Safety is easing regulations required for the development of biosimilars (generic versions of biopharmaceuticals). The aim is to reduce development time and costs by allowing the omission of Phase 3 clinical trials and the submission of data from certain animal experiments if specific requirements are met. The Ministry announced on the 14th that it is amending and implementing the "Regulations on Product Approval an…

연합뉴스-Yonhap News Agency

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(Seoul = Yonhap News) Reporter Park Sang-hyun = Requirements for Phase 3 clinical trials and animal testing of biosimilars (biologically equivalent drugs) will be relaxed.