Proposed biosimilar shows equivalence to golimumab in rheumatoid arthritis
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Key takeaways:
- Alvotech’s AVT05 showed therapeutic equivalence with golimumab in DAS28-CRP score change at 16 weeks.
- The positive topline results are the first announced for a golimumab biosimilar.
A biosimilar for golimumab has demonstrated therapeutic equivalence in rheumatoid arthritis, with no clinically meaningful safety differences, according to a press release from the manufacturer.
The topline results, announced by Alvotech, stem from a confirmatory clinical study for AVT05, the company’s proposed biosimilar to the TNF alpha inhibitors Simponi and Simponi Aria (golimumab, Janssen Biotech).
“We are delighted at passing yet another clinical milestone in our pipeline,” Robert Wessman, chairman and CEO of Alvotech, said in the release. “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.”
The randomized, double-blind multicenter study, called AVT05-GL-C01, compared the efficacy, safety and immunogenicity of the proposed biosimilar with golimumab combined with methotrexate in patients with moderate to severe RA. According to ClinicalTrials.gov, enrollment for the trial totaled 502 individuals. The primary outcome was change from baseline in DAS28-CRP response at week 16.
According to the release, the study met its primary endpoint, with results demonstrating therapeutic equivalence between AVT05 and golimumab. In addition, there were no clinically meaningful differences in safety through week 24.
The data follow previous topline results from a pharmacokinetic study into AVT05 announced by Alvotech in November. That study, which assessed the pharmacokinetics, safety, and tolerability of the biosimilar vs. E.U.-approved and U.S.-licensed versions of golimumab in 336 healthy adults, similarly met its primary endpoint.
“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,” read the release.
References:
Study Details | Comparative, multicenter study in subjects with rheumatoid arthritis, ALVOFLEX. https://clinicaltrials.gov/study/NCT05842213. Published Sept. 21, 2023. Accessed April 25, 2024.
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