ACR Convergence 2025| Video: Rheum for Everyone, Episode 26—Ableism

An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

60-Day Comment Period Opens for FDA’s Draft Guidance on Biosimilars

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Submit written comments via mail to the Dockets Management Staff (HFA-305), U.S. Food & Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with docket number FDA-2011-D-0605. Comments can also be submitted electronically.

The FDA will review and consider all public comments before finalizing the guidance.

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Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

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  1. 9 things to know about biosimilars and interchangeable biosimilars. U.S. Food & Drug Administration. 2024 Jun 20.
  2. AAM, Biosimilars Council. Letter RE: Biosimilar Red Tape Elimination Act (S. 1954). 2025 Jul 7.
  3. Hassan M. Lee, Hassan bill cuts drug prices and red tape. 2025 Jun 4.
  4. Center for Drug Evaluation and Research, Office of New Drugs, Office of Therapeutic Biologics and Biosimilars. Scientific considerations in demonstrating biosimilarity to a reference product: Updated recommendations for assessing the need for comparative efficacy studies. Draft guidance for industry. Docket Number: FDA-2011-D-0605. 2025 Oct 28.

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