Alvotech’s share price jumps after FDA approval for new Simlandi manufacturing process

The U.S. Food and Drug Administration (FDA) has approved a new manufacturing method for Simlandi, a biosimilar drug made by Alvotech, according to reports from Vísir, RÚV, and Iceland Monitor.

Following the announcement, Alvotech’s share price rose by about 7% in trading on Tuesday. The approval comes after what analysts described as the company’s toughest year yet, with expectations now turning to significant revenue growth in the future, according to Vísir.

Alvotech, which is based in Iceland, said that the new FDA-approved manufacturing method would allow the company to double the amount of active pharmaceutical ingredient it can produce for Simlandi. This could help the company meet higher demand for Simlandi, a biosimilar to Humira, which is one of the world’s best-selling biotech drugs.

Reporting from mbl.is indicated that this is the second FDA approval Alvotech has secured, though further details on the prior approval were not disclosed.

TopicsAlvotechBiosimilarsFDAHumiraPharmaceuticalsSimlandi