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BIO Comments on FDA Draft Guidance on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations

July 19, 2019

BIO submitted comments on the Food and Drug Administration (FDA) Draft Guidance, Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.

BIO welcomes the guidance on using comparative analytical studies to assess whether a proposed therapeutic protein product is biosimilar to a reference product for purposes of submitting a marketing application under section 351(k) of the Public Health Service (PHS) Act.  In the comments, BIO provides specific changes to clarify the guidance.

Download Full Comments Below
FINAL BIO Comments Comparative Analytical Assessment And Other Quality-Related Considerations
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