Business
Alvotech Reports Financial Results for First Nine Months of 2022 And Provides Business Update
Revenue for first nine months of 2022 increased to $59.2 million, compared to $2.0 million for the same period in 2021Discussions with U.S. FDA progressed
About this update from Alvotech
[{"type":"text","content":"Revenue for first nine months of 2022 increased to $59.2 million, compared to $2.0 million for the same period in 2021Discussions with U.S. FDA progressed regarding both biologic license applications for AVT02 (adalimumab); aiming to launch in the U.S., if approved, on July 1, 2023; additional regulatory approvals granted in major marketsContinued pipeline progression with submission of marketing applications for AVT04, biosimilar candidate to Stelara®, in major markets including the U.S. and EUManagement to conduct a business update conference call and live webcast on Wednesday, November 16, 2022 at 8:00 am ET (13:00 pm GMT) REYKJAVIK, ICELAND (November 15, 2022) — Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported unaudited financial results for the first nine months of 2022 and provided a summary of recent corporate highlights. “Submission of new regulatory applications, further approvals and expanded commercial partnerships demonstrate strong progress of our strategy and continued commitment to our vision for the biosimilars market,” said founder and Executive Chairman of Alvotech, Robert Wessman. “We are engaging with the FDA to resolve outstanding issues regarding manufacturing site inspection status and anticipate meeting our launch date of July 1, 2023 for our proposed biosimilar to Humira® in the U.S., with the potential to be the first high-concentration, interchangeable biosimilar.” Pipeline and Partnership Highlights Presented AVT02 switching study data at American College of Rheumatology Conference 2022Alvotech presented two posters and held an Ignite Talk outlining data from a switching study conducted to investigate the pharmacokinetics (PK), immunogenicity, efficacy and safety in patients undergoing repeated switches between Humira® and AVT02. The results of the switching study, which demonstrate bioequivalence of repeated switches between administration of Humira® and AVT02 to administration of Humira® without switching, were included in Alvotech’s interchangeable Biologics License Application, which was accepted for filing by the FDA in February 2022. Reported update on initial AVT02 Biologics License Application: Alvotech received communication in September 2022 from the U.S. Food and...