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…
