3 December 2018 - 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.”