Alvotech Reports 10% Revenue Growth for 2023, Secures FDA Approval for Humira Biosimilar

Biopharmaceutical company Alvotech announced its full-year 2023 financial results, reporting a 10% increase in total revenues to $93.4 million. Product revenues nearly doubled to $48.7 million from $24.8 million in 2022, with fourth-quarter 2023 product revenues rising 37% year-over-year.

The U.S. Food and Drug Administration (FDA) approved Alvotech's Simlandi, a biosimilar to Humira, granting it interchangeable status. Simlandi is the first high-concentration, citrate-free adalimumab biosimilar to receive this designation in the U.S. Additionally, Alvotech's biosimilar to Stelara, Jamteki, launched in Canada, with anticipated launches in Japan and Europe later in 2024.

Alvotech also reported positive top-line results from confirmatory efficacy studies for its proposed biosimilar to Eylea (aflibercept) and pharmacokinetic studies for biosimilar candidates targeting Prolia/Xgeva (denosumab) and Simponi/Simponi Aria (golimumab). These clinical advancements support the company's integrated development and manufacturing platform.

The company raised approximately $166 million through a share issuance to fund general corporate purposes, enhance production capacity, and support upcoming biosimilar launches. As of December 31, 2023, Alvotech's cash and cash equivalents were $11.2 million, increasing to approximately $172 million on a pro forma basis after accounting for the recent equity financing.