Form 483 un­masks man­u­fac­tur­ing is­sues at Alvotech be­fore its CRL, and one for Au­robindo too

Ear­li­er this month, the Ice­landic biotech Alvotech re­ceived a re­sponse let­ter from FDA sur­round­ing its po­ten­tial in­ter­change­able biosim­i­lar to Ab­b­Vie’s Hu­mi­ra, which dis­cussed sev­er­al …

Sign up to read this article for free.

Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER