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Biosimilars: BIO Comments on FDA Draft Guidance : Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.

July 19, 2019

Re: Docket No. FDA-2019-D-2102-0001: Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations

Dear Sir/Madam:

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.

BIO welcomes this well written Draft Guidance on the use of comparative analytical studies that are relevant to assessing whether the proposed product is biosimilar to a reference product for purposes of submission of a marketing application under section 351(k) of the PHS Act. Furthermore, we welcome the document’s description of considerations for CMC information that is relevant to assessing whether the proposed product is biosimilar to the reference product. BIO is supportive of the Agency’s decision to combine the comparative analytical assessment within the previously issued “Quality Considerations” draft guidance rather than as a standalone guidance.

BIO appreciates this opportunity to submit comments on the Draft Guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.  We provide additional specific, detailed comments to improve the clarity of the Draft Guidance in the following chart. We would be pleased to provide further input or clarification of our comments, as needed.