Policy Update: FDA Releases Three Draft Guidances on Biosimilars
February 9, 2012
The FDA just released three draft guidances on biosimilars, as well as a Fact Sheet and Q and A document. Read BIO's press release: Release of FDA Guidance for Biosimilars Pathway Marks Important Step Forward, Says BIO and visit the FDA website for more information:
Draft Guidances
- Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the BPCI Act of 2009
- Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (PDF - 576KB)
- Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product (PDF - 432KB)
- Fact Sheet: Issuance of Draft Guidances on Biosimilar Product Development
- Questions and Answers: Issuance of Three Draft Guidance Documents on Biosimilar Product Development
