Pfiz­er fi­nal­ly fin­ish­es a 3-year reg­u­la­to­ry odyssey, bag­ging an FDA OK for 1st Epogen knock­off

A decade af­ter Hos­pi­ra launched its biosim­i­lar of Am­gen’s ag­ing ane­mia drug Epogen in Eu­rope, its suc­ces­sors at Pfiz­er have fi­nal­ly pushed it over the fin­ish line at the FDA. The ap­proval of the first Epogen copy­cat to­day — sold by J&J as Pr­o­crit — comes af­ter their knock­off Re­tacrit was snubbed twice at the FDA, first in 2015 and again last sum­mer, when reg­u­la­tors voiced dis­sat­is­fac­tion with their man­u­fac­tur­ing cen­ter.

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