FDA stalls yet an­oth­er Her­ceptin copy­cat, is­su­ing re­sponse let­ter to Am­gen/Al­ler­gan

In a some­what un­sur­pris­ing set­back, Am­gen $AMGN and its part­ner Al­ler­gan got snubbed by the FDA Fri­day on the duo’s biosim­i­lar ap­pli­ca­tion for their Her­ceptin copy­cat ABP 980. Ex­pect­ed on­ly be­cause the FDA has al­ready de­layed two oth­er Her­ceptin biosims from My­lan and Pfiz­er.

Just days ago, Am­gen/Al­ler­gan’s drug ABP 980 got ap­proval from reg­u­la­tors in Eu­rope, where it can now sell un­der the brand name Kan­jin­ti. The drug can be used to treat ear­ly breast can­cer, metasta­t­ic breast can­cer, and metasta­t­ic gas­tric can­cer.

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