The Biosimilars Forum Joins Calls for FDA Action on Biosimilar Communications

The Biosimilars Forum is lending its support to Pfizer’s August 2018 citizen petition to the FDA to clarify appropriate sponsor communications about biosimilars.

In a comment letter signed by the organization's president, Juliana M. Reed, and submitted to the federal docket last week, the Biosimilar Forum said that it supports Pfizer’s petition and identification of misinformation practices “by entities inside and outside the biosimilars community.” Misinformation, it said, detracts from confidence in these FDA-regulated medicines.

The Forum underscored Pfizer’s statements that multiple biologic manufacturers have issued communications related to biosimilars’ safety and efficacy, “in public communications readily viewed by physicians, their patients, and the public in general,” that contain misleading information. As such, said the comment letter, “it is evident that supplemental guidance from the FDA is required to ensure that reference product sponsors, as well as other organizations more generally, understand how to communicate about biosimilars in a manner reflected under current law.”

Helpful guidance, added the Forum, should establish best practices by including examples of inappropriate communication, describing the types of communications that are inappropriate, and providing examples of communications that are suitable.

Additionally, according to the comment letter, the FDA should enhance its current biosimilar education programs to providing materials that will explicitly counter misinformation.

In a statement provided to The Center for Biosimilars^®, the Forum said that it is “firmly committed to improving awareness about the effectiveness of biosimilars and combating misinformation about their safety. In order to ensure that patients are able to benefit from these life-saving treatments, any efforts to undermine confidence in biosimilars must be taken seriously and responded to appropriately.” The statement called for the FDA to directly respond to organizations that conduct “biosimilar misinformation campaigns” to request the immediate suspension and withdrawal of misleading information, and include a “Facts about Biosimilars” page on its website to ensure that the national dialogue about biosimilars is fact-driven.

The Forum is the second major entity to weigh in with support for Pfizer’s petition in recent days; also in November, Novartis, parent company of biosimilar developer Sandoz, submitted a similar letter to the FDA in support of the petition. In its letter, Novartis said that the FDA and HHS “could do more to incentivize the use of biosimilars while still ensuring access to and development of novel biological products,” and called for FDA action and oversight “to help ensure a truthful environment exists within which healthcare providers and patients can make treatment decisions without harmful misinformation about biosimilars.”