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FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.
FDA released final guidance documents on biosimilar products on Apr. 28, 2015. The three documents are: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; and Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.
The documents address comments from various industry perspectives and, according to FDA, “are intended to provide predictability and to make clear the scientific and regulatory considerations for sponsors initiating biosimilar development programs.”