EMA Accepts AVT05 MAA from Alvotech and Advanz Pharma

The European Medicines Agency (EMA) has reviewed a marketing authorisation application (MAA) for AVT05, a biosimilar to Johnson & Johnson’s Simponi (golimumab), developed by Alvotech and Advanz Pharma. This marks the first global MAA submission for a Simponi biosimilar targeting chronic inflammatory conditions.

AVT05 is designed to be similar to both Simponi and Simponi Aria, which are used to treat chronic inflammation. The approval process for this biosimilar is anticipated to be completed by the fourth quarter of 2025.

This submission follows a commercialization agreement between Alvotech and Advanz Pharma from February 2023 for AVT23, another proposed biosimilar to Novartis’ Xolair (omalizumab). Their collaboration expanded in May 2024 to include five more biosimilar candidates, such as AVT05 and AVT16, alongside three additional undisclosed early-stage candidates. By June 2024, the companies also agreed to commercialize two biosimilars, AVT06 and AVT29, aimed at different dosage forms of Eylea.

Joseph McClellan, Alvotech's chief scientific officer, commented on this achievement, emphasizing the significance for partners, patients, and caregivers. He highlighted the advantage of having internal capabilities and expertise to use a host cell line and processes similar to those used for the reference biologic, giving them an edge in developing the Simponi biosimilar.

In April 2024, Alvotech revealed positive top-line results from a confirmatory trial, indicating AVT05's comparable safety, efficacy, and immunogenicity to Simponi in treating moderate to severe rheumatoid arthritis. Earlier in November 2023, they published favorable outcomes from a pharmacokinetic study comparing AVT05 to Simponi in healthy adults.

Golimumab, the active component of Simponi, is a monoclonal antibody that targets TNF alpha, a substance involved in systemic inflammation. Furthermore, the US Food and Drug Administration approved a presentation for SELARSDI (ustekinumab-aekn), a joint product by Alvotech and Teva Pharmaceuticals, for treating adults with ulcerative colitis and Crohn’s disease.