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.

Tentative agreement closely resembles FDA's original proposal.

Extrapolation and interchangeability appear to be the linchpins for biosimilar sponsors mulling whether to send applications to the emerging 351(k) pathway or the traditional novel biologics approval system.