Taking issue with Amgen, Genentech and other reference product sponsors’ dissemination of misleading information on biosimilars, Pfizer is asking the 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 “mischaracterize important elements of the biosimilar criteria and create doubt and confusion about the safety and efficacy of biosimilars.”
For instance, a textual summary comparing biosimilars and generics on a Genentech website explains that the “FDA requires a biosimilar to be highly similar, but not identical to the [reference product],” but Pfizer notes that the explanation “fails to state that an approved biosimilar must have no clinically meaningful differences from the reference product.”
Similarly, an Amgen YouTube video implies that switching to a biosimilar from a reference product is risky, though a recent review found the opposite. Pfizer also points to Remicade ads from Janssen Biotech that failed to mention a biosimilar works in the same way as the reference product.
Request for FDA
In calling for the FDA to craft a new guidance on what’s misleading and what isn’t, Pfizer also asks for the guidance to address reference product sponsor communications comparing reference biologics to biosimilars, including interchangeable biosimilars, “that would and would not be considered misleading.
“Promotional statements by a reference product sponsor that directly or implicitly communicate that biosimilar products differ from interchangeable products in any regard beyond the additional data required to permit substitution without physician intervention at the pharmacy level are plainly misleading,” Lisa Skeens, VP of global regulatory affairs at Pfizer, wrote.
Skeens calls on the FDA to target certain ads or promotional materials that sow confusion and mistrust among patients and physicians. And Pfizer also wants the FDA to clarify that biosimilar sponsors may discuss clinical and other data with physicians and in promotional materials.
She also notes that while it’s generally out of the FDA’s purview, “payer reimbursement policies are in fact impeding adoption of biosimilars,” though “dissemination of false or misleading information about the safety or efficacy of biosimilars, whether to patients and prescribers or directly to payers, has the potential to affect payer decisions about biosimilar reimbursement, as well as patient and healthcare professional confidence in biosimilars.”
First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email firstname.lastname@example.org for more information.
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