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.
"This isn't trivial. It's not copycat stuff," says Mike Kamarck, president of Merck & Co. Inc.'s three-year-old Merck BioVentures unit, about developing biosimilar drugs. It's clear to everyone in, or entering, the biosimilars game that creating biologic copies is more expensive and far more complicated than what’s required to make chemical generics. It also involves a whole new set of regulatory requirements – very fresh indeed in the US – which push up biosimilars' development costs and affect their market positioning.
That's in essence why branded Big Pharma like Merck and Pfizer Inc. have entered the game, believing they can...
