This application marks the first global MAA filing for a biosimilar candidate to Simponi for treating chronic inflammatory conditions. Credit: BlurryMe/Shutterstock.

The European Medicines Agency (EMA) has accepted a marketing authorisation application (MAA) for Alvotech and Advanz Pharma’s AVT05, a proposed biosimilar to Johnson & Johnson’s (J&J) Simponi (golimumab).

The application marks the first global MAA filing for a biosimilar candidate to Simponi, a biologic for treating chronic inflammatory conditions.

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AVT05 is being developed as a biosimilar to both Simponi and Simponi Aria (golimumab). The approval process for AVT05 is expected to conclude by the fourth quarter (Q4) of 2025.

This development follows Alvotech and Advanz Pharma’s initial commercialisation agreement in February 2023 for AVT23, a Novartis’ Xolair (omalizumab) biosimilar.

Alvotech and Advanz Pharma expanded their strategic partnership in May 2024 to include five additional biosimilar candidates, along with AVT05, AVT16 and three early-stage biosimilar candidates which have not been disclosed.

In June 2024, both companies entered a commercialisation agreement for two biosimilar candidates to Eylea, AVT06 and AVT29, targeting different dosage presentations.

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Alvotech chief scientific officer Joseph McClellan stated: “This is a welcome milestone for us, our partners, patients and caregivers, as we take one step closer to being able to offer access to biosimilar Simponi.

“We believe having the capability and know-how inhouse to utilise a host cell line and process also used to manufacture the reference biologic, has given us an important head start in developing a biosimilar candidate to Simponi.”

Alvotech announced positive top-line results from a confirmatory trial in April 2024, demonstrating comparable safety, efficacy and immunogenicity between AVT05 and Simponi in treating moderate to severe rheumatoid arthritis.

In November 2023, Alvotech released positive topline results from a pharmacokinetic study comparing AVT05 to Simponi in healthy adults.

Golimumab, the active ingredient in Simponi, is a monoclonal antibody that targets tumour necrosis factor-alpha (TNF alpha), a substance involved in systemic inflammation.

The US Food and Drug Administration recently approved a presentation for SELARSDI (ustekinumab-aekn), a collaborative product of Alvotech and Teva Pharmaceuticals, for treating adults with ulcerative colitis and Crohn’s disease.