FDA Releases Program for Approval of Biosimilars DOCUMENT: Draft Guidance for Industry from FDA: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product DOCUMENT: Draft Guidance for Industry from FDA: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
Available accessResearch articleFirst published online April, 2012
FDA Releases Program for Approval of Biosimilars DOCUMENT: Draft Guidance for Industry from FDA: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product DOCUMENT: Draft Guidance for Industry from FDA: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product