Continuing its battle to improve the uptake of its biosimilar infliximab, Pfizer accused Janssen Biotech, Amgen, and Roche of making false claims about the safety and efficacy of biosimilars in comparison with their originator products. In Pfizer’s citizen’s petition, it has requested that the US Food and Drug Administration (FDA) intervene.
“We request that the [FDA] issue guidance to ensure truthful and non-misleading communications by sponsors concerning the safety and effectiveness of biosimilars, including interchangeable biologics, relative to reference product(s),” Pfizer stated in the petition.
Dated August 22, Pfizer’s citizen’s petition claimed that the reference manufacturers had engaged in “inappropriate communications” and “misleading representations and suggestions.” Although Pfizer does not allege false claims by these drug makers, it does challenge that the statements they are making suggest that the biosimilars may not result in equivalent outcomes.
The petition alludes to the FDA’s recent statements and actions in favor of improving access to biosimilars and speeding their approval and introduction. Pfizer quoted FDA Commissioner Scott Gottlieb’s statements earlier this year in announcing the agency’s Biosimilar Action Plan as well as at a meeting of America’s Health Insurance Plans, where he said, “Physician and patient confidence in the quality and safety of biosimilar products is critical to their market acceptance. And at FDA, we want to address any misconceptions or concerns that may be out there.”
At the heart of the issue is materials directed at physicians and patients that “mischaracterize important elements of the biosimilar criteria and create doubt and confusion about the safety and efficacy of biosimilars,” according to Pfizer’s citizen’s petition.
In specific examples cited by Pfizer:
- On a Genentech website: “FDA requires a biosimilar to be highly similar, but not identical to the [reference product].” Pfizer believes this is misleading because Genentech does not “state that an approved biosimilar must have no clinically meaningful differences from the reference product.”
- On an Amgen website: “Biologics or biosimilars? It’s not just apples to apples. While #biosimilars may be highly similar to their #biologic reference products, there’s still a chance that patients may react differently. See what you’re missing without the suffix”
- From Janssen marketing materials: “You may be asked to switch to a biosimilar that works in a similar way to REMICADE.” Pfizer explains that the “The BPCIA explicitly states that a biosimilar is highly similar to the reference product but has the same mechanism of action, meaning that a biosimilar works in the same way as the reference product.”
Although none of these messages would rise to the level of false advertising, they do attempt to raise doubt in the minds of the patient and physician. This has been one of the chief methods in the reference manufacturer’s playbook since 2012 (and since the introduction of the Hatch–Waxman Act decades earlier with regard to generic drug marketing). The real question is whether the FDA’s 351(k) approval process has addressed these issues adequately. Judging from physician and patient attitudes these days, it would seem less damaging than Pfizer might claim.
At the same time, this might be an opportunity to strengthen FDA’s hand in use of language characterizing the quality of biosimilars and their anticipated clinical outcomes.