Biosimilars Forum Calls for FDA Guidance to Address Misinformation

Regulatory NewsRegulatory News | 03 December 2018 |  By 

Echoing a Pfizer petition and Novartis comments, the Biosimilars Forum said late last week that guidance from the US Food and Drug Administration (FDA) is needed to ensure reference product sponsors and other organizations communicate properly about biosimilars.
Amgen, which withdrew from the Forum recently, Roche’s Genentech and others have been singled out for misinformation campaigns that not only question the legal framework governing biosimilars but also the safety of switching to a biosimilar.
“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,” the Forum said.
Such guidance should include examples of inappropriate communications about the safety and efficacy of biosimilars. The guidance should also describe the types of communications that promote doubt, and FDA should provide examples of what types of communications are not misleading or harmful, thus establishing a set of FDA-approved best practices for communicating about biosimilars.
And after the guidance is issued, the Forum urges FDA to send communications to organizations that still conduct biosimilar misinformation campaigns. The agency should request the immediate suspension and withdrawal of such campaigns, the Forum says.
Similarly, Novartis encourages FDA to publish on its website a "Facts about Biosimilars" page addressing the most common pieces of misinformation, including suggestions that switching from a reference product to a biosimilar may not be safe and inferences that the quality of a product that is "only" a biosimilar is not as good as an interchangeable biosimilar.
The Forum also requests that FDA enhance its current biosimilar education and outreach programs to provide explicit materials to counter misinformation campaigns.

In response to the criticism, Amgen told Focus that it is committed to the "educational communication of factual, balanced information regarding biosimilars and their use, and believe such communications help build the confidence necessary to ensure biosimilar uptake." As an example, the company pointed to its education campaign on nonproprietary naming, called "Circle the Suffix," to help physicians and pharmacists understand the importance and appropriate use of the suffix.

Updated on 12/4/18 with Amgen comment.


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