New FDA Guidance On Biosimilar Interchangeability
July 3, 2019
Life Science Leader
By Amanda K. Murphy, Ph.D.; Jeffrey M. Jacobstein; Yicong Du*
On May 09, 2019, the U.S. FDA issued final guidance titled “Considerations in Demonstrating Interchangeability with a Reference Product.” It is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262[k]).
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*Yicong Du is a Summer Associate at Finnegan
Originally printed in Life Science Leader on 7/3/19. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm's clients.
