FDA ex­perts wave through Pfiz­er's copy­cat of an ane­mia med from Am­gen, J&J, but a le­gal chal­lenge still re­mains

Pfiz­er had no prob­lem con­vinc­ing an ex­pert pan­el at the FDA that its biosim­i­lar of Am­gen’s block­buster ane­mia med Epogen and Pr­o­crit, mar­ket­ed by J&J, should get a quick green light for mar­ket­ing.

The ex­perts lined up 14 to 1 in fa­vor of the ap­proval, no big sur­prise giv­en the agency’s clear en­dorse­ment in its writ­ten re­view from agency in­sid­ers. Their bot­tom line:

The to­tal­i­ty of an­a­lyt­i­cal da­ta sup­port the de­ter­mi­na­tion that “Epo­et­in Hos­pi­ra” is high­ly sim­i­lar to US-li­censed Epogen/Pr­o­crit notwith­stand­ing mi­nor dif­fer­ences in clin­i­cal­ly in­ac­tive com­po­nents.

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