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.”

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER