FDA hands No­var­tis the keys to a $5B Am­gen fran­chise

No­var­tis has bagged an FDA ap­proval for Erelzi (etan­er­cept-sz­zs), its biosim­i­lar of En­brel. And now the phar­ma gi­ant is good to go on every in­di­ca­tion En­brel is mar­ket­ed for in the U.S. in­clud­ing rheuma­toid arthri­tis, plaque pso­ri­a­sis, pso­ri­at­ic arthri­tis, anky­los­ing spondyli­tis and pol­yartic­u­lar ju­ve­nile id­io­path­ic arthri­tis.

The ap­proval gives No­var­tis the keys to a mar­ket worth $5 bil­lion a year to Am­gen, which tried to block this wide-rang­ing reg­u­la­to­ry OK in the key US mar­ket. The fight is like­ly far from over though. Am­gen has moved its rear-guard ac­tion to the courts, a strat­e­gy which has proven far more ef­fec­tive in block­ing this first wave of biosim­i­lars and the dis­counts they promise.

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