Biosim­i­lars go 2-0 in an FDA dou­ble-head­er fa­vor­ing No­var­tis, Am­gen

Now that the FDA ad­vi­so­ry com­mit­tee brought to­geth­er on biosim­i­lars has had a chance to brush up on the agency’s reg­u­la­to­ry frame­work and ob­jec­tives, the out­side ex­perts had lit­tle trou­ble reach­ing for an­oth­er unan­i­mous de­ci­sion en­dors­ing No­var­tis’s copy­cat of En­brel.

The vote was 20-0 in fa­vor, re­flect­ing the agency’s in­sid­er opin­ion that No­var­tis—which scored the first ap­proval for a biosim­i­lar in the U.S. and has a whole line­up be­ing prepped for an OK—has per­fect­ed the de­vel­op­ment process. Com­ing swift­ly on the heels of an­oth­er bright green light yes­ter­day for Am­gen’s biosim­i­lar of Ab­b­Vie’s $14 bil­lion fran­chise drug Hu­mi­ra, there’s con­sid­er­ably less mys­tery about what man­u­fac­tur­ers need to do to win ap­provals in this new but fast grow­ing field.

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