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.

European regulators’ guidelines on biosimilars show that they are serious about quickly approving cheaper follow-on biologics. The hurdles may come thereafter.

Europe's summertime flurry of private biotech sell-offs points to growing pragmatism among management and VCs, and still-poor valuations on the public markets. Firms which haven't already considered the trade sale opportunity should do so--even early-stage, pre-product platform groups.

A long-awaited Food and Drug Administration (FDA) workshop held in mid-September, highlighted just how far the agency is from establishing a regulatory path for generic copies of biologics. Although it yielded few surprises, the meeting provided a concentrated public forum for interested parties to present in-depth views of all sides of the issue--an unusual event in itself