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# Guidance on Biosimilar Communication Backed
- URL: https://www.fdaweb.com/guidance-on-biosimilar-communication-backed/
- Published: 2019-02-27T12:00:00.000Z
- Updated: 2026-09-15T01:08:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143478

Two drug stakeholders say they support a request in a Pfizer 8/22/18 citizen petition that FDA issue guidance to ensure truthful and non-misleading communications by reference product sponsors on biosimilar safety and effectiveness, including interchangeable biologics, relative to the reference products. The Association for Accessible Medicines and its Biosimilars Council [say](https://www.regulations.gov/document?D=FDA-2018-P-3281-0012&ref=fdaweb.com) the few launched biosimilar medicines in the U.S. have been slow to gain market share, to the detriment of patients and the U.S. health system.

The groups’ comment letter says the low market share for biosimilars “is largely due to tactics used by some originator biologic companies that abuse their dominant market position to create barriers to biosimilar approval and uptake. As Pfizer has highlighted in their citizen petition, a prominent anti-competitive tactic employed by some originator manufacturers is to sow seeds of doubt regarding the safety and efficacy of FDA-approved biosimilars through misleading communication to prescribers and patients.”

The two generic drug groups say they support Pfizer’s request for FDA guidance and also believe that additional action is needed, such as agency Warning Letters to drug makers engaged in misinformation campaigns and coordination with the Federal Trade Commission to address anticompetitive behavior that interferes with biosimilar development, approval, and marketplace competition.

The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, also [supports](https://www.regulations.gov/document?D=FDA-2018-P-3281-0011&ref=fdaweb.com) the petition request for guidance. “We agree that the biosimilar marketplace needs FDA’s help to foster a sustainable and competitive marketplace where patients and prescribers have confidence in the safety and efficacy of FDA-licensed biologics, both innovator and biosimilars,” the association writes. “We urge the agency to provide a framework whereby the veracity of claims by manufacturers or others with respect to biosimilars can be judged.”

PCMA says the FDA guidance should cover: 

- misleading representations and suggestions made by reference product sponsors that biosimilars are not as safe or effective as their reference products;
- representations or suggestions made by reference product sponsors that biosimilar products are inferior to interchangeable biologics in terms of quality or similarity to the reference product; and
- communications by reference product sponsors that suggest that biosimilar products cannot be prescribed to both treatment-naïve and treatment-experienced patients.