Biosimilars price tagged at $300M

It costs $300 million and takes eight years to create a biosimilar drug, according to Mark McCamish, global head of biopharmaceuticals and oncology injectables development at Sandoz. "Looking at the complexity of doing biosimilars, this is not for the faint of heart," McCamish told BioCentury. The cost and expertise needed to create biosimilars will reduce competition, but within five years there will be three or four companies competing to market biosimilar versions of the same innovator biologics, he predicted.

The user fee goal for FDA action on Sandoz's application to market Zarxio, the first application to market a biosimilar in the U.S., is March 8. Zarxio, which is marketed around the world as Zarzio, is a biosimilar version of Neupogen filgrastim G-CSF from Amgen Inc. (NASDAQ:AMGN) (see BioCentury, Jan. 12). ...