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BIO Comments on FDA Draft Guidance on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations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BIO submitted comments on the Food and Drug Administration (FDA) Draft Guidance, Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.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

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