"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 compete through bringing innovation – albeit not of the traditional,...
