Biosimilarity and Interchangeability

 

The U.S. FDA has issued a document titled ‘Additional Draft Q&As on Biosimilar Development and the BPCI Act’.  This draft guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

 

The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar products and proposed interchangeable products, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.

 

See: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biosimilarity-and-interchangeability-additional-draft-qas-biosimilar-development-and-bpci-act

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)