FDA Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
Title:
FDA Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
Origin/Publisher:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291128.pdf
Document Type:
Scientific Considerations
Content:
provides guidance to companies which must demonstrate the boisimilarity of a therapeutic protein product to a existing reference product. The guidance recommended a stepwise risk-based "totality-of-the-evidence" approach to evaluate the biosimilarity to the reference product relating to structure, function, animal toxicity pharmacokinetics and pharmacodynamics, clinical immunogenicity, and clinical safety and effectiveness.