FDA OKs lower-cost al­ter­na­tive to biotech drug Hu­mira

Daily Local News (West Chester, PA) - - WEATHER - By Matthew Per­rone AP Health Writer

Fed­eral reg­u­la­tors on Fri­day ap­proved the first al­ter­na­tive ver­sion of the sec­ond-best sell­ing drug in the world, Hu­mira, the block­buster in­jec­tion used to treat rheuma­toid arthri­tis and other in­flam­ma­tory dis­eases.

The Food and Drug Ad­min­is­tra­tion cleared a near-copy of the drug, dubbed Am­je­vita, de­vel­oped by Am­gen Inc. Reg­u­la­tors ap­proved the drug for more than a half-dozen con­di­tions listed on the orig­i­nal drug’s la­bel, in­clud­ing se­vere pso­ri­a­sis and Crohn’s dis­eases.

Hu­mira posted sales of nearly $15 bil­lion in 2015 and was for many years the top-sell­ing pre­scrip­tion drug in the world, ac­cord­ing to data from IMS Health.

It’s the fourth time that the FDA has for­mally ap­proved a so-called biosim­i­lar, the in­dus­try term for a lower-cost ver­sion of a biotech drug. Biosim­i­lar drugs, long avail­able in Europe, are thought to have the po­ten­tial to gen­er­ate bil­lions in sav­ings for the U.S. health sys­tem.

But cur­rently only one biosim­i­lar cleared by the FDA ap­proval path­way is ac­tu­ally on the mar­ket in the U.S., No­var­tis’ Zarxio, an al­ter­na­tive to Am­gen’s Ne­u­pogen that sells for about 15 per­cent less than the orig­i­nal prod­uct. The drug helps boost red blood cells in cancer pa­tients.

Am­gen did not dis­cuss plans for the drug’s launch or price in a re­lease is­sued Fri­day evening.

But Wall Street an­a­lysts have noted that Ab­bVie claims it holds patents pro­tect­ing Hu­mira un­til at least 2022. They have pre­vi­ously es­ti­mated that Am­gen’s ver­sion could launch some­time be­tween 2018 and 2022, depend­ing on the out­come of court lit­i­ga­tion.

First ap­proved in 2002, Hu­mira ac­counted for 60 per­cent of Ab­bVie’s to­tal rev­enue last year. The in­jectable drug, which blocks chem­i­cals linked to in­flam­ma­tion, is part of a fam­ily of biotech drugs in­clud­ing En­brel and Rem­i­cade, which are also fac­ing pend­ing biosim­i­lar com­pe­ti­tion.

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