An interesting Citizen Petition popped up earlier this week in which pharma giant Pfizer has requested FDA guidance on sponsor communications about biosimilar products. This is not a new campaign for Pfizer, who has emphasized the need to address anticompetitive exclusionary practices, “misinformation,” and market access issues with respect to biosimilars for at least the last year. Pointing to the same anticompetitive behavior that FDA Commissioner Gottlieb has admonished recently in both the biosimilar and the generic space, Pfizer raises concerns that the lack of market confidence in biosimilars resulting from the proliferation of false and misleading information by reference product sponsors has stymied market acceptance and uptake.
We’re used to seeing big pharma companies on the other side of these types of petitions – brand name sponsors are more often accused of exclusionary behavior than attempting to combat it. But the biosimilar market is a different beast than the traditional small molecule generic market. With resource-rich companies acting as both reference product and biosimilar sponsors, the game can be played a little differently. Indeed, Pfizer has approval for two biosimilars, RETACRIT (epoetin alfa-epbx) and NIVESTYM (filgrastim-aafi), and is a commercial partner to Celltrion Healthcare with respect to INFLECTRA (infliximab-dyyb), in addition to several BLAs.
Looking to Europe’s “robust” uptake of biosimilars, Pfizer’s Citizen Petition posits that payer incentives and inducements to switch patients to biosimilars is an effective strategy to encourage widespread acceptance of biosimilars. Though Pfizer praised FDA’s efforts to foster biosimilar development and adoption, including the recently announced Biosimilars Action Plan, the Citizen Petition cited the payer reimbursement policies and the dissemination of false or misleading information about biosimilars as the biggest obstacles to biosimilar acceptance in the U.S. Pfizer recognizes that payer decisions about reimbursement are outside of the FDA’s purview, but instead encourages FDA to take steps to ensure that reference product sponsors disseminate only truthful and nonmisleading information in an effort to help shape payers’ views on biosimilars and their reimbursement.
Specifically, Pfizer alleged that “certain reference product sponsors . . . disseminate false and misleading information that casts doubt about the safety and efficacy of biosimilars in the minds of patients and prescribers.” The Citizen Petition includes examples of some of the alleged false and misleading information disseminated by reference product sponsors that undermines public confidence in the safety and effectiveness of biosimilars, including:
- A textual summary comparing biosimilars to generics on a sponsor’s website explains that “FDA requires a biosimilar to be highly similar, but not identical to the [reference product]”, but fails to state that an approved biosimilar must have no clinically meaningful differences from the reference product.
- A recent tweet suggesting that biosimilars are not the same as the biologics they reference: “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: http://bit.ly/2G2zGTa.”
- A patient brochure stating that a “biosimilar is not approved as interchangeable . . . ” and “switching or alternating back and forth between the interchangeable biologic and [the reference product] would not cause any changes in safety or how well the treatment works – no infliximab biosimilar has yet proven this.”
According to Pfizer, these statements create confusion as to biosimilarity and interchangeability, inflate the risks associated with a physician-directed switch to a biosimilar, and cast doubt of the safety and efficacy of biosimilars generally.
To address these concerns, Pfizer’s Citizen Petition requests that FDA publish Guidance advising on communications characterizing reference products and biosimilars. The Guidance should address misleading representations and suggestions that biosimilars are not as safe or effective as corresponding reference products; misleading comparisons and implied reference product superiority claims; and claims that sow mistrust among patients and physicians in biosimilar products. Additionally, Pfizer asks FDA to provide examples of communications that would not be considered false or misleading in addition to clarification that a biosimilar sponsor may discuss with physicians and in promotional materials clinical and other data for a biosimilar product whether or not such data is included in the biosimilars labeling.
Given FDA’s commitment to biosimilars and to addressing the high costs of medicines, it wouldn’t be surprising if the Therapeutic Biologics and Biosimilars Staff is already hard at work establishing some sort of guidelines for communication about the relationship between biologic reference products and biosimilars. Indeed, FDA has emphasized the need to develop “effective communications to improve understanding of biosimilars among patients, clinicians, and payors.” But it’s still early in the implementation of the Biosimilar Action Plan, and FDA will be hearing many more suggestions about the biosimilars marketplace next week.