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