Topline results from a confirmatory clinical study for AVT 05, a proposed biosimilar for Simponi (golimumab)

Alvotech 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.

Worldwide revenues in 2023 from sales of Simponi and Simponi Aria were approximately $3.2 billion

Simponi patents expire on 1 February 2024 in US and on 1 October 2024 in EU.

The AVT05-GL-C01 confirmatory clinical study (NCT05842213) is a randomized, double-blind, 2-arm, multicenter confirmatory clinical study to investigate the efficacy, safety, and immunogenicity between subcutaneous AVT 05 and EU Simponi in patients with moderate to severe rheumatoid arthritis. The primary outcome measure is change from baseline to week 16 in DAS28-CRP, which is a disease activity score measurement for rheumatoid arthritis. The study met its primary endpoint, with results demonstrating therapeutic equivalence between AVT 05 and Simponi. Additionally, no clinically meaningful differences in safety were observed through week 24.

In November 2023 Alvotech announced positive topline results from a pharmacokinetic study (NCT05632211) for AVT 05, which assessed the pharmacokinetics, safety, and tolerability of AVT 05 compared to EU approved Simponi and US-licensed Simponi in 336 healthy adult subjects. All three study treatments were given at a single dose of 50 mg/0.5 mL pre-filled syringe, via a subcutaneous injection. The study met its primary endpoints.