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• The FDA has released draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act”
• The draft guidance is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable products, as well as describe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• The draft guidance is to be published in the Federal Register on Nov 20, 2020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 ­to­ read full press release/ article | Ref: Big Molecule Watch  | Image: FDA