On August 22, 2018, Pfizer submitted a citizen petition to the Food and Drug Administration requesting “guidance clarifying appropriate sponsor communications about the nature and properties of biosimilar products.” Specifically, Pfizer petitioned FDA to clarify what constitutes a false and misleading communication with respect to the safety and effectiveness of biosimilars relative to reference products. The petition was posted online on Monday, August 27.
Pfizer noted that the United States lags behind the EU in biosimilars’ achievement of cost improvements, market acceptance, and patent access. While Pfizer acknowledged that this trend may be due in part to the fact that the United States passed the BPCIA about five years later than similar legislation was passed in the EU, Pfizer also suggested that false and misleading statements regarding biosimilar safety and effectiveness contributes to the problem, for example, by influencing payer decisions about reimbursement for biosimilars. In support of this position, Pfizer noted a few specific examples of allegedly false and misleading statements about biosimilars made by reference product sponsors in their promotional materials.
Pfizer also highlighted FDA’s prior statements articulating its commitment to encouraging biosimilar competition, as well as Commissioner Scott Gottlieb’s recent acknowledgement of weak sales and the need for “effective communications to improve understanding of biosimilars.”
The citizen petition requests that the FDA provide specific examples of appropriate and inappropriate communications regarding biosimilars in support of the Food, Drug and Cosmetic Act’s prohibition against misbranding. In particular, Pfizer noted that the BPCIA’s statutory framework requires that biosimilars be “highly similar” to their reference product, with “no clinically meaningful differences.” Therefore, the petition contended, statements omitting or misstating this standard, making unsubstantiated comparisons, or suggesting that a reference product is superior to a biosimilar, should be avoided. The petition specifically argued that to avoid creating doubt or confusion in the minds of consumers, materials stating that biologics and biosimilars are not identical should also state that they do not bear any clinically meaningful differences to the reference product. The petition further argued that certain uses of the term “interchangeability” in marketing materials should be clarified or avoided.
FDA spokeswoman Lyndsay Meyer has declined to comment on the petition, saying only that “FDA has received the petition and will respond directly to the petitioner.”
Comments on Pfizer’s petition will be accepted until February 23, 2019.
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