2015: US Biosimilars’ Year of Reckoning

This year will be one of reckoning for US biosimilars: the four known submissions to the FDA’s biosimilar pathway will between them stress test all aspects of the regulatory framework. The coming months will determine how far FDA can go in support of biosimilars – and how far innovators are prepared go in defense of their portfolios.

This year will be one of reckoning for US biosimilars. The four known submissions to the FDA’s biosimilar pathway will between them stress-test all aspects of the regulatory framework. Within as little as six months from now – hemmed in by the pathway’s 10-month review time – FDA will be forced to show its hand on the appropriate balance of analytical versus clinical data, on non-proprietary naming, on labeling, and on indication extrapolation across four different molecules of varying size and complexity.

Granted, FDA has always maintained that it will consider each candidate on a case-by-case basis. But the quartet of

More from Archive

More from In Vivo