FDA of­fers No­var­tis a thumbs-up on En­brel biosim­i­lar as Am­gen plays of­fense/de­fense si­mul­ta­ne­ous­ly

On Fri­day, the FDA gave Am­gen a clean bill of health for its biosim­i­lar of Ab­b­Vie’s Hu­mi­ra. To­day, it’s Am­gen’s turn to watch a megablock­buster go un­der the biosim­i­lar gun, as the FDA of­fers a clear thumbs up to No­var­tis’ knock­off of the $9 bil­lion drug En­brel.

Two days ahead of a pan­el re­view, FDA in­sid­ers said that No­var­tis’ gener­ics di­vi­sion San­doz had of­fered all the da­ta need­ed to con­clude that the copy­cat was good for all in­di­ca­tions Am­gen sells En­brel for in the U.S. The FDA’s in­sid­er con­clu­sion:

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER