Alvotech fails pre-ap­proval in­spec­tion for its pro­posed Hu­mi­ra in­ter­change­able biosim­i­lar

Al­most a dozen new Hu­mi­ra biosim­i­lars will fi­nal­ly launch in the US next year, be­gin­ning with Am­gen’s in Jan­u­ary (al­most four years be­hind Eu­rope), but one of the top fol­low-on con­tenders, with a high­er con­cen­tra­tion ver­sion and a po­ten­tial in­ter­change­able des­ig­na­tion to boot, has now been stalled due to man­u­fac­tur­ing is­sues.

Alvotech re­vealed Mon­day that the FDA sent along a re­jec­tion let­ter that iden­ti­fied “cer­tain de­fi­cien­cies re­lat­ed to the Reyk­javik fa­cil­i­ty and stat­ed that sat­is­fac­to­ry res­o­lu­tion of the de­fi­cien­cies is re­quired be­fore FDA may ap­prove” the biosim­i­lar ap­pli­ca­tion.

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