From Interchangeability To Exclusivity: US FDA Looks For Ways To Make Biologics Market More Competitive
The agency is being urged to help spur biosimilar development and market success by finalizing guidance on interchangeability, enhancing public education efforts, and taking a more forceful approach to combating misinformation, while reference product sponsors want FDA to adopt 'umbrella' exclusivity to encourage innovative changes in novel biologics.
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Citizen petition requests agency guidance that specifies what communications are false and misleading; Pfizer cites a Janssen Remicade brochure and Amgen YouTube video that suggest switching to biosimilars could lead to different outcomes.
In unveiling the agency’s Biosimilar Action Plan, FDA's Gottlieb continued his pattern of provocative remarks by criticizing brand company practices and payment models that impede biosimilar competition and could ultimately undermine innovation. He also called for more action by the Federal Trade Commission and downplayed the impact interchangeability could have on biosimilar uptake.
Pfizer filed a lawsuit against J&J over its efforts to block sales of Pfizer's biosimilar Inflectra through exclusive contracting for Remicade. The suit claims J&J coerced payers by vowing to withhold all Remicade rebates if any Inflectra is reimbursed. J&J says Pfizer has failed to show the value of Inflectra.