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FDA Considering Biosimilars ‘Guardrails’

US Agency May Take Steps To Prevent Misinformation In Communications

 
• By Sue Sutter

Agency wants to ensure patients ‘aren’t unnecessarily or unfairly scared off or intimidated’ from taking biosimilars, Office of Therapeutic Biologics and Biosimilars' acting policy director Eva Temkin tells the FDA/CMS Summit; Temkin says recent guidance on biosimilar insulins shows agency is trying to be flexible on interchangeability data requirements.

Guardrail_Road
Communications about biosimilars may require some guardrails • Source: Shutterstock

The US Food and Drug Administration is considering policies to ensure communications about biosimilars and interchangeable biosimilars do not scare patients away from using the products, an agency official said on 4 December.

While the FDA has been focused on proactively communicating information about the safety and efficacy of biosimilars, it also is...

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