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# Therapeutic Protein Biosimilars Draft Guide
- URL: https://www.fdaweb.com/therapeutic-protein-biosimilars-draft-guide/
- Published: 2019-05-22T12:00:00.000Z
- Updated: 2026-09-15T01:28:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144162

*Federal Register* notice: FDA has released a draft guidance on “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” The document describes the agency’s recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product. Additionally, it provides recommendations to sponsors on the scientific and technical information for the chemistry, manufacturing, and controls portion of a marketing application for a proposed biosimilar product. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-05-22/pdf/2019-10667.pdf?ref=fdaweb.com).