FDA Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product"
Title:
FDA Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein 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/UCM291134.pdf
Document Type:
Guidance for Industry
Content:
This document comprises information about analytical factors and the importance of extensive analytical, physico-chemical and biological characterisation of a Biosimilar. These factors are unalienable to demonstrate highly similarity to a reference product.