Guideline on biosimilar medicines

Update: 25 November, 2023

This document describes the regulatory framework for biosimilar medicines in the European Union, including their definition, development and approval procedures, and the safety of biosimilar medicines.

File format: PDF

Size: 1974 KB

MD5 Checksum: 09CCCA663896BD7B9DADC4658EB9D14B

Publication date: 25 November, 2023

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PDF Link: Guideline on biosimilar medicines PDF

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