Pfizer Calls for FDA Guidance on False or Misleading Information About Biosimilars

“Misleading statements...and the net impression conveyed by such materials, create undue confusion as to biosimilarity and interchangeability, inflate the risks associated with a physician-directed switch to a biosimilar, and cast doubt on the safety and efficacy of biosimilars generally,” read Pfizer's citizen petition.

Pfizer has submitted a citizen petition to the FDA in which the biosimilar developer asks the agency to issue guidance clarifying how drug sponsors may communicate about biosimilars. “Just as there is a need for policies that support innovation, there is also a need for policies that ensure that patients and physicians have truthful and non-misleading information that encourages appropriate uptake of biosimilars so that biosimilars can reach their full potential for patients,” read the petition.

In the August 22, 2018, document, Lisa M. Skeens, PhD, vice president of global regulatory affairs for Pfizer Essential Health, writes on behalf of the company that a key factor in the slow growth of the biosimilars market in the United States stems from “the efforts of certain reference product sponsors to disseminate false and misleading information that casts doubt about the safety and efficacy of biosimilars in the minds of patients and prescribers,” and that misinformation communicated to payers is hindering the development of reimbursement policies that could help encourage biosimilar use.

Read more about Pfizer's claims concerning anticompetitive actions in the biosimilars market.

Pfizer cited multiple communications from reference product sponsors as misleading, including the following:

  • Genentech’s “Examine Biosimilars” website, which states that “the FDA requires a biosimilar to be highly similar, but not identical to the existing biologic medicine.” Pfizer argues that Genentech’s omission of the fact that an approved biosimilar must have no clinically meaningful differences from its reference product is a failure to properly communicate the definition of a biosimilar.
  • Janssen Biotech’s patient brochure for brand-name Remicade, which states that a biosimilar works “in a similar way” to a biosimilar without clarifying that the biosimilar must have the same mechanism of action as the originator. Pfizer also takes issue with the brochure’s suggestion that no infliximab biosimilar has been proven to be safe or effective in a switching study.
  • Amgen’s April 13, 2018, tweet that states that patients may react differently to biosimilars than to reference products. Pfizer also points out an Amgen YouTube video that implies that switching to a biosimilar is unsafe for patients who are well controlled on a current therapy.

“Misleading statements like these, and the net impression conveyed by such materials, create undue confusion as to biosimilarity and interchangeability, inflate the risks associated with a physician-directed switch to a biosimilar, and cast doubt on the safety and efficacy of biosimilars generally,” read the petition.

Pfizer applauded the FDA for its efforts on educating stakeholders about biosimilars, including its Biosimilar Education and Outreach Campaign, website updates, and plans to develop more educational resources and host additional webinars on biosimilars. “While these efforts are laudable,” Pfizer said, they do not go far enough to address communications by reference product sponsors that undermine efforts to communicate the safety and efficacy of biosimilars, and are not a substitute for FDA guidance on the topic.

The petition goes on to ask for specific clarifications that Pfizer hopes to see in an FDA guidance document:

  • Clarification that any promotional statements made by a sponsor that suggest that a biosimilar is not as safe or effective as its reference are misleading and unlawful.
  • Specification that reference product sponsors cannot suggest that biosimilars without interchangeable designations are inferior to those that have been deemed interchangeable.
  • Description of types of false or misleading claims.
  • Clarification that biosimilar product sponsors can discuss a product’s clinical data or other data with physicians and in promotional materials.

“Issuing a guidance document that addresses the areas identified above will help to ensure that communications concerning the safety and effectiveness of biosimilars, including interchangeable biologics, do not inhibit the use of and reliance on biosimilars for therapeutic treatment,” the petition said.

Pfizer’s document also stated that the FDA has the statutory authority under the Food, Drug, and Cosmetic Act to prohibit the distribution of a product—such as a reference biologic—if it is misbranded, and suggested that communications that suggest that a reference product is superior to a biosimilar might meet the standard of misbranding. However, the petition stopped short from calling on the FDA to restrict marketing of reference products on this basis.

This is not the first time that Pfizer has attempted to push back against reference product sponsors that it deems to be obstructing the biosimilar marketplace; in 2017, it filed a lawsuit against Johnson & Johnson (J&J), saying that the company threatened to withhold rebates from insurers unless they agreed to exclude biosimilars from their formularies.

While J&J sought to have the case dismissed, earlier this month, the district court for the Eastern District of Pennsylvania denied J&J’s motion, saying that “Pfizer’s Complaint sufficiently alleges that it has suffered an antitrust injury as the result of J&J’s anticompetitive conduct. J&J’s efforts to foreclose Pfizer from the market, as Pfizer has alleged, have led to increased prices for consumers and limited competitive options for end payors, providers, and patients.”

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