Pfizer’s Biosimilar Program: A MAB Dash After Biocon Deal Ends
This article was originally published in The Pink Sheet Daily
Following the breakup in March of its insulin biosimilars deal with Biocon, Pfizer confirms plans to develop monoclonal antibody biosimilars on its own, and has put its first candidate, rituximab, into Phase 1 testing.
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The company has biosimilars of Rituxan, Herceptin and Remicade in clinical trials and a biosimilar to Humira is about to enter Phase I; Pfizer is pursuing the biosimilar pathway for all of its candidates.
The limited discussion of interchangeability in FDA’s initial biosimilar draft guidances has left some stakeholders clamoring for more details. Others say the agency’s demand for a “higher standard” of evidence to show interchangeability is misplaced and will inhibit use of the 351(k) pathway.
The lesson from first-generation biosimilars is that these aren't just small-molecule style copies. They require significant clinical and commercial support to overcome prescriber skepticism. For those lining up to tap into the next-generation opportunity, biosimilars represent a new kind of innovation, where the novelty lies in a drug's value-focused pricing, quality, cost-effective production, and in peripherals such as support-services and means of delivery. Although biosimilar market dynamics will vary from molecule to molecule, this emphasis on price and value rather than scientific breakthrough exemplifies a new definition of innovation in the biopharma sector.