FDA de­ci­sion could mean more com­pe­ti­tion for Am­gen

Modern Healthcare - - THE WEEEK AHEAD - —Steven Ross John­son

Am­gen is brac­ing for yet an­other drug to com­pete with its bi­o­logic med­i­ca­tions.

A U.S. Food and Drug Ad­min­is­tra­tion ad­vi­sory panel is sched­uled to con­sider ap­proval Wed­nes­day of a biosim­i­lar cre­ated by San­doz, No­var­tis’ generic arm. The panel will ad­vise the FDA, which makes the fi­nal call.

San­doz’s GP2015 would mark the fourth biosim­i­lar the com­pany has de­vel­oped to com­pete with Am­gen bi­o­log­ics. Last Septem­ber, San­doz be­came the first com­pany to launch a biosim­i­lar in the U.S. af­ter re­ceiv­ing FDA ap­proval in March 2015 for Zarxio, a biosim­i­lar ver­sion of Am­gen’s can­cer med­i­ca­tion Ne­u­pogen.

Ac­cord­ing to San­doz’s web­site, the com­pany has at least two other biosim­i­lar ver­sions for Am­gen drugs in de­vel­op­ment. They in­clude one for Am­gen’s ane­mia med­i­ca­tion Epogen and its block­buster can­cer treat­ment Neu­lasta.

The es­ti­mated im­pact on the high cost of bi­o­log­ics, some of which can cost sev­eral thou­sands of dol­lars a month, has var­ied. Ini­tial pro­jec­tions when Zarxio was ap­proved had the drug be­ing sold at a 30% to 35% dis­count to Ne­u­pogen.

Once Zarxio was of­fi­cially launched, the list­ing price re­flected only a 15% dis­count from the price of Ne­u­pogen.

The FDA ad­vi­sory panel Tues­day also will con­sider the ap­pli­ca­tion for ap­proval of Am­gen’s own biosim­i­lar ver­sion of Ab­bVie’s best-sell­ing arthri­tis drug Hu­mira.

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