No­var­tis silent­ly yanks a trou­bled biosim­i­lar ap­pli­ca­tion; Chi­nese an­ti­body de­vel­op­er draws $39M round

• No­var­tis nev­er has tried to ex­plain why the FDA has re­ject­ed its biosim­i­lar of Am­gen’s Neu­las­ta. And it’s be­ing equal­ly ret­i­cent about its de­ci­sion to yank its ap­pli­ca­tion in Eu­rope. The “ap­pli­ca­tion for a mar­ket­ing au­tho­riza­tion for Ziox­ten­zo (peg­fil­gras­tim) has been with­drawn,” the EMA not­ed to­day. “Ziox­ten­zo was de­vel­oped as a biosim­i­lar med­i­cine to treat neu­trope­nia in can­cer pa­tients.” No­var­tis loves to high­light its R&D progress, but set­backs are dealt with silent­ly. The EMA, though, did ex­plain that the biosim­i­lar ap­peared to be un­ap­prov­able.  “One con­cern was that study re­sults were not able to show that the con­cen­tra­tions of peg­fil­gras­tim in blood were the same af­ter tak­ing Ziox­ten­zo and Neu­las­ta. The oth­er con­cern was the lack of a cer­tifi­cate of Good Man­u­fac­tur­ing Prac­tice (GMP) for the med­i­cine’s man­u­fac­tur­ing site. An in­spec­tion of the site will there­fore be need­ed be­fore the med­i­cine can be ap­proved.”

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