Personal Library

FDA guidance

FDA. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Guidance for Industry. April 2015. 

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf

Accessed January 19, 2016.

351(k) abbreviated licensure pathway.

42 USC 262(k). Licensure of biological products as biosimilar or interchangeable. 

http://uscode.house.gov/view.xhtml?path=&req=%28title%3A42+section%3A262+edition%3Aprelim%29&f=&fq=&num=0&hl=false&edition=prelim

Accessed January 19, 2016.