Alvotech reports increased revenue, secures regulatory progress for biosimilars
Biotechnology firm Alvotech reported a rise in product revenue for the first nine months of 2023 and provided updates on regulatory progress for its biosimilar candidates in Japan, Canada, and Europe. The company is preparing for facility inspections by the U.S. FDA in early 2024.
Biotechnology company Alvotech has reported significant progress in its biosimilar development and commercialization efforts. Product revenue for the first nine months of 2023 reached $29.8 million, a substantial increase from $11.1 million in the same period last year. This revenue growth stems from the sales of Alvotech's products in European and Canadian markets.
Alvotech secured marketing authorizations for its AVT04 product in Japan and Canada. This product is a biosimilar to Stelara® (ustekinumab), marking the first approval for a Stelara biosimilar in these regions. Furthermore, the European Medicines Agency (EMA) has issued a positive opinion for AVT04's marketing authorization within the European Economic Area, with a final decision pending from the European Commission.
The company is also advancing the approval process for AVT02 and AVT04 in the United States. Regulatory approval is contingent upon facility inspections by the U.S. Food and Drug Administration (FDA), scheduled for January 2024. Alvotech anticipates these inspections will proceed successfully, paving the way for potential U.S. market approvals within 2024.
Additionally, Alvotech has entered into a licensing agreement with Kashiv Biosciences for the development and commercialization of AVT23, a biosimilar candidate for Xolair® (omalizumab). Under this agreement, Kashiv will manage development and manufacturing, while Alvotech will leverage its global partnerships and market expertise for commercialization. The company also announced the receipt of $140 million in financing through convertible bonds during the third quarter.