Alvotech’s FDA Approval and Stock Surge

Alvotech experienced a significant rise in its shares during premarket trading following a crucial U.S. regulatory approval for its biosimilar to Humira. In addition, the biotechnology company agreed to a $166 million stock sale.

FDA Approval for Simlandi

Alvotech, in collaboration with Teva Pharmaceuticals, announced that the U.S. FDA granted approval for its Simlandi injection as an interchangeable biosimilar to Humira. This approval covers various treatments, including adult rheumatoid arthritis, juvenile idiopathic arthritis, and more.

Interchangeable Status

Simlandi is recognized as the first high-concentration, citrate-free biosimilar to Humira to achieve interchangeability. This allows for substitution at the pharmacy without prescriber consultation, similar to generic drugs.

Collaboration Details

As part of their partnership agreement from 2020, Alvotech manages biosimilar development and manufacturing, while Teva handles U.S. commercialization. The launch of Simlandi in the U.S. is anticipated soon with interchangeability status.

Stock Sale and Utilization of Proceeds

In conjunction with these developments, Alvotech agreed to sell over 10.1 million shares at $16.41 each. The proceeds from this sale will enhance production capacity and support the launch of biosimilars.

Stock Performance

Following these announcements, Alvotech’s U.S.-listed shares saw a significant surge of over 12%, reaching $18 in premarket trading from their previous closing price of $16.03.