28 August 2018 - Taking issue with Amgen, Genentech and other reference product sponsors’ dissemination of misleading information on biosimilars, Pfizer is asking the US FDA to take action with new guidance on what’s acceptable.

In a citizen petition filed Monday, Pfizer notes examples of what it calls “inappropriate communications” and “misleading representations and suggestions by reference product sponsors.” The issue at hand isn’t so much that the information is wrong, but that the statements imply that biosimilars are not as safe or as effective as reference products.

Pfizer says it has observed some reference product sponsor-created physician- and patient-directed materials that “mischaracterise important elements of the biosimilar criteria and create doubt and confusion about the safety and efficacy of biosimilars.”

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