Alvotech Gets US FDA Approval For Additional Manufacturing Capacity For Simlandi Biosimilar; Shares Up Pre-Bell
MT Newswires Live
Oct 05
Alvotech (ALVO) has received US Food and Drug Administration approval for a supplement to the biologics license application for AVT02, marketed as Simlandi in the US, the company said Monday.
The move allows drug substance for the product to be manufactured in a second production suite at the company's facility in Reykjavik, Iceland, and further confirms resolution of FDA inspection-related matters at the site.
Simlandi is Alvotech's biosimilar to Humira.
The company's shares were up 5.9% in premarket activity.
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