With biosim­i­lars gain­ing mo­men­tum, Am­gen and Al­ler­gan cite suc­cess of Her­cept­in's copy­cat

Am­gen and Al­ler­gan are re­port­ing a new suc­cess for their part­ner­ship aimed at de­vel­op­ing a slate of four big biosim­i­lars. In­ves­ti­ga­tors re­port­ed that ABP 980 was vir­tu­al­ly in­dis­tin­guish­able from Roche’s $6.5 bil­lion fran­chise drug Her­ceptin (trastuzum­ab) in pa­tients with hu­man epi­der­mal growth fac­tor re­cep­tor 2-pos­i­tive (HER2-pos­i­tive) ear­ly breast can­cer in a Phase III tri­al.

The re­sults set up an­oth­er shot at a near-term ap­proval, fol­low­ing Am­gen’s so­lo suc­cess in front of an FDA pan­el re­view a week ago for its biosim­i­lar of Ab­b­Vie’s $14 bil­lion fran­chise drug Hu­mi­ra. A day lat­er Am­gen was play­ing de­fense, try­ing to slow No­var­tis’s ef­fort to win an ap­proval for a biosim­i­lar of En­brel, a $9 bil­lion gold mine for Am­gen and its part­ners.

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