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• The FDA has released draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act”
• The draft guidance is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable products- as well as describe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• The draft guidance is to be published in the Federal Register on Nov 20- 2020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