Novartis Calls for FDA Enforcement Against Biosimilar Misinformation
Posted 15 November 2018 | By
Building off a Pfizer citizen petition on biosimilar misinformation, Novartis is calling on FDA to set the record straight on what information can be disseminated.
The misinformation campaigns, as explained in Pfizer’s petition
from August, “further demonstrate efforts to foster fear and highlight hypothetical yet unproven risks associated with the use of FDA-approved biosimilars,” Novartis said.
Amgen, Genentech and others are called out for these campaigns that not only question the legal framework enacted by Congress but also question the safety of switching to a biosimilar, “thereby questioning the validity of an FDA decision that a biosimilar is safe and effective for use,” Novartis said.
The company encourages FDA to publish on its website a "Facts about Biosimilars" page addressing the most common pieces of misinformation including what’s been said in relation to the level of confidence in the safety and efficacy of biosimilars in all labeled indications, including extrapolated indications; 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. FDA is also urged to be more explicit in encouraging stakeholders to model their education messaging on FDA's materials.
“In its correspondence to infracting organizations, FDA should identify the specific campaign, demand the immediate withdrawal of the materials, warn against any future misinformation campaigns, provide accurate information that counters the misinformation and include information about the FDA's legal and regulatory framework to review and approve biosimilars,” Novartis said.
“In addition, FDA should establish a publicly available website identifying each organization engaged in biosimilar misinformation campaigns. The list should be available on FDA's website, identify the organizations by name, provide a brief summary of the misinformation, and provide corrected or accurate information.”