FDA Updates Biosimilar Q&A Draft Guidance
FDA has released updated draft guidance on biosimilar development, clarifying how sponsors can use non-U.S.-licensed comparator products to support biosimilarity and what is required during FDA review.
FDA Announces New Steps to Streamline Biosimilar Development
FDA Announces New Steps to Streamline Biosimilar Development FDA Takes Additional Steps to Support Biosimilar Development The U.S. Food and Drug Administration has announced new actions aimed at streamlining the development of biosimilar medicines and improving access...