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# Stakeholders Comment on Biosimilars Labeling Guidance
- URL: https://www.fdaweb.com/stakeholders-comment-on-biosimilars-labeling-guidance/
- Published: 2020-04-07T12:00:00.000Z
- Updated: 2026-09-14T16:10:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146513

Kaiser Permanente says an FDA question-and-answer draft guidance on promotional labeling and advertising considerations for prescription biological reference and biosimilar products “will help abate misinformation campaigns that unfairly reduce patient and prescriber confidence in biosimilars.” The health system’s comment [letter](https://www.regulations.gov/document?D=FDA-2019-D-5473-0006&ref=fdaweb.com) also encourages the agency to build on its efforts to ensure clinicians and patients have ready access to accurate information about biosimilars that can help counter misinformation campaigns. And it says FDA should consider how it can help increase access to unbiased safety and effectiveness data about biosimilars, convene non-conflicted experts to provide product-specific counter-detailing, and disseminate more patient- and provider-friendly resources providing accurate information about biosimilars.

The Blue Cross Blue Shield Association [says](https://www.regulations.gov/document?D=FDA-2019-D-5473-0003&ref=fdaweb.com) it appreciates the agency’s clarification that “representations or suggestions that create an impression that there are clinically meaningful differences between the reference product and its biosimilar … are likely to be false and misleading.” The association also says it supports FDA efforts to ensure that providers and patients have unbiased information available to them about the benefits of biosimilars and it urges the agency to finalize the guidance as soon as possible.

Pfizer [says](https://www.regulations.gov/document?D=FDA-2019-D-5473-0007&ref=fdaweb.com) it believes it is essential to avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway and thus FDA should address interchangeable biosimilar labeling and promotional materials to help ensure that they avoid representing or suggesting that a biosimilar product is less safe or effective because it has not been designated as interchangeable.