On April 23, 2024, Alvotech announced “positive topline results from a confirmatory clinical study for AVT05,” Alvotech’s proposed golimumab biosimilar to Janssen Biotech, Inc.’s SIMPONI(R) and SIMPONI ARIA(R). According to Alvotech, the confirmatory clinical study (NCT05842213) was a randomized, double-blind, two-arm, multicenter clinical study designed to investigate the therapeutic equivalency of AVT05 and SIMPONI(R) for the treatment of rheumatoid arthritis. The study met its primary endpoint, supporting AVT05’s therapeutic equivalency, and showed no clinically meaningful differences in safety through 24 weeks. Alvotech states that it “is the first company to announce positive topline results of a clinical trial using a proposed biosimilar to Simponi and Simponi Aria and is one of only two companies known to have initiated such a patient study.”
AVT05 has not yet received regulatory approval. Following the confirmatory clinical results, Alvotech announced its intention to file marketing applications for AVT05 later this year.