Róbert Wessman, Alvotech CEO

Trou­bled Reyk­javik plant lands Alvotech a sec­ond CRL for its po­ten­tial Hu­mi­ra biosim­i­lar

Bil­lion­aire Róbert Wess­man’s Alvotech is con­tin­u­ing to run in­to man­u­fac­tur­ing de­fi­cien­cies at a Reyk­javik plant, lead­ing to a sec­ond com­plete re­sponse let­ter for its po­ten­tial Hu­mi­ra in­ter­change­able biosim­i­lar, the com­pa­ny an­nounced last night.

While not go­ing in­to the specifics of the man­u­fac­tur­ing prob­lems, Ice­land-based Alvotech said the FDA con­clud­ed its in­spec­tion of the Reyk­javik site on March 17, and point­ed to is­sues that “must be sat­is­fac­to­ri­ly re­solved be­fore the ap­pli­ca­tion can be ap­proved.”

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