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Pharmaceuticals / Regulatory Affairs

Pfizer Calls for Guidance on Misleading Biosimilar-Related Communications

Oct. 8, 2018

In a citizen petition, Pfizer asked the FDA to issue draft guidance to prevent misleading communications by reference drug sponsors on the effectiveness of biosimilars.

The drugmaker cites a rash of what it says are inappropriate or misleading communications by reference drug sponsors that imply biosimilars are inferior to their reference products, despite the fact that the Public Health Service Act requires the FDA to determine a biosimilar has no clinically meaningful difference from the reference drug.

The petition cites materials from Janssen that say consumers “may be asked to switch to a biosimilar that works in a similar way” to its drug Remicade, phrasing that wrongly implies a biosimilar would have a different mechanism of action. Pfizer also cites a YouTube video by Amgen that advises against switching to a biosimilar “if your medicine is working for you”.

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