Alvotech Lines Up US Biosimilar Approvals After FDA Inspection
AVT02 Adalimumab And AVT04 Ustekinumab Approvals Expected Early This Year
Alvotech has revealed details of exactly when it expects to win US FDA approvals for its Teva-partnered Humira and Stelara biosimilars, after an agency reinspection of its manufacturing plant in Reykjavik, Iceland resulted in just a single “readily addressable” Form 483 observation.
