Alvotech Announces Topline Results from a Confirmatory Clinical Study for AVT05, a Proposed Biosimilar for Simponi (golimumab)

• The confirmatory clinical safety and efficacy study for AVT05, biosimilar candidate to Simponi and Simponi Aria (golimumab), met its primary endpoint in patients with moderate to severe rheumatoid arthritis
  
• Alvotech is the first company to publicly announce positive topline results from a patient study evaluating a biosimilar candidate to Simponi or Simponi Aria
  

REYKJAVIK, Iceland, April 24, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive topline results from a confirmatory clinical study for AVT05, Alvotech’s proposed biosimilar to Simponi and Simponi Aria (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.

“We are delighted at passing yet another clinical milestone in our pipeline,” said Robert Wessman, Chairman and CEO of Alvotech. “We intend to file marketing applications for AVT05 in major global markets this year, which adds to the continued diversification of our portfolio and further demonstrates the capabilities of our biosimilar-dedicated platform.”

Worldwide revenues in 2023 from sales of Simponi and Simponi Aria were approximately $3.2 billion [1].

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 AVT05 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 AVT05 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 AVT05, which assessed the pharmacokinetics, safety, and tolerability of AVT05 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.