Proposed Golimumab Biosimilar AVT05 Meets Primary Endpoints in Moderate to Severe RA

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At the end of the trial, the study met its primary outcome, indicating therapeutic equivalence between the biosimilar (AVT05) and reference golimumab.

Alvotech’s proposed golimumab biosimilar, AVT05, met its primary endpoints in a confirmatory clinical study evaluating the biosimilar for the treatment of moderate to severe rheumatoid arthritis (RA).1

“We are delighted at passing yet another clinical milestone in our pipeline,” Robert Wessman, Chairman and CEO of Alvotech, said in a statement. “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.”1

Alvotech, the first company to announce positive results from a trial evaluating a golimumab biosimilar, is only 1 of 2 companies to have initiated a patient study in this area.

The Drug

AVT04 inhibits tumor necrosis factor alpha (TNF-α), which has been shown to impact several chronic inflammatory diseases, including RA, psoriatic arthritis (PsA), and anylosing spondylitis. The biosimilar has not been granted regulatory approval in any country and biosimilarity has not been established by regulatory authorities.

Golimumab for the Treatment of RA

Results of a previous retrospective, longitudinal, single-arm study using the Rheumatology Informatics System for Effectiveness (RISE) registry to evaluate disease activity in patients switching from intravenous infliximab to intravenous golimumab indicated golimumab was an effective therapy for RA. The registry contains information about demographics, laboratory results, disease activity, diagnoses, medication, and procedures from 1.6 million patients.2

At enrollment, most adult patients with RA reported moderate to high disease activity (Clinical Disease Activity Index [CDAI]: 73% [38/52]). The mean age was 65.3 years, 81% were female, and 74% were White. Of the eligible patients with a baseline and follow-up rheumatoid arthritis disease activity (RADA) measure, 100 and 63 had -golimumab persistence at the ≥ 6 and ≥ 9 month follow-ups, respectively.2

Of the 52 patients with CDAI information available at 6 months, patients showed significant improvements in disease activity, with scores improving from 21.3 to 14.1 (P <.0001), which remained through 12 months. Disease activity decreased from 73% to 56% and low or remitted disease activity increased from 27% to 44% (P <.001).2

The Current Study

The randomized, double-blind, 2-arm, multicenter confirmatory clinical study, AVT05-GL-C01, was designed to determine the safety, efficacy, and immunogenicity between the proposed biosimilar and reference drug in patients with moderate to severe RA. The primary endpoint was the change from baseline to week 16 in Disease Activity Score-28 for Rheumatoid Arthritis with C-reactive protein (DAS28-CRP).

At the end of the trial, the study met its primary outcome, indicating therapeutic equivalence between the biosimilar and reference product. Further, there were no clinically meaningful differences in safety through week 24.

Previously, Alvotech announced positive topline results from another pharmacokinetic study for the biosimilar, which evaluated the safety, tolerability, and pharmacokinetics of AVT05 compared with the European-approved and US-licensed reference product in a cohort of 336 health adult patients. In this study, all participants received a single dose of each study treatment via subcutaneous injections of 50 mg/.5 mL pre-filled syringes.3

Regarding the recent developments of the TNF-α inhibitor, Momna Ali, healthcare analyst at GlobalData said, “Despite the mature RA market, there is an unmet need, particularly concerning cost-effective therapies and earlier diagnosis. Although biosimilarity has not been established yet, the fact that AVT05 has progressed to phase 3 alludes to a promising pipeline candidate.”3


  1. Alvotech. Alvotech announces topline results from a confirmatory clinical study for AVT05, a proposed biosimilar for Simponi® (golimumab). GlobeNewswire News Room. April 24, 2024. Accessed April 24, 2024.
  2. Pine L. Golimumab improves disease activity in patients with RA. HCP Live. February 28, 2023. Accessed April 24, 2024.
  3. Cameron I. Alvotech’s avt05 emerges as leading contender in rheumatoid arthritis market. biopharma. October 12, 2023. Accessed April 24, 2024.