On January 27, 2025, Alvotech and Teva announced FDA acceptance of the Biologics License Application (BLA) for AVT05, a proposed biosimilar to SIMPONI and SIMPONI ARIA. This marks the first U.S. BLA acceptance for a golimumab biosimilar, an anti-TNF therapy for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The FDA review is expected to conclude in Q4 2025.
In April 2024, Alvotech announced positive results from a confirmatory clinical study comparing efficacy, safety, and immunogenicity between AVT05 and SIMPONI in patients with moderate to severe rheumatoid arthritis. In November 2023, Alvotech had announced AVT05’s comparable performance to SIMPONI in healthy adult participants based on a pharmacokinetic study.
Since August 2020, Alvotech and Teva have partnered for the exclusive commercialization of five of Alvotech’s biosimilar product candidates, including AVT05. Alvotech handles development and manufacturing, while Teva is responsible for the commercialization in the United States.
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