FDA’s Draft Guidance for Industry Seeks to Answer Questions on Biosimilar Interchangeability
FDA has published new draft guidance for industry titled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.”
The draft guidance supplements two prior documents concerning biosimilar interchangeability published in December 2018. This new guidance, in particular, has some useful information for prospective applicants who seek licensure of an “interchangeable” biosimilar product.