The US FDA Draft New Guidelines for Biosimilarity and Interchangeability
Shots:
- The FDA has released draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act”
- The draft guidance is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable products- as well as describe FDA’s interpretation of statutory requirements added by the BPCI Act
- The draft guidance is to be published in the Federal Register on Nov 20- 2020
Source 1- Source 2 Ref: Big Molecule Watch | Image: FDA
Click here to read the full press release
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