Ema Clears Way for Gobivaz, Alvotech's Proposed Golimumab Biosimilar, in Europe

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for the marketing of AVT05, a proposed biosimilar to the drug Simponi (golimumab) developed by Alvotech. The European Commission will grant marketing authorization after CHMP's positive opinion. Alvotech and its marketing partner Advanz Pharma are working to increase access to golimumab for patients and healthcare professionals.

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing approval for AVT05, a proposed biosimilar to the drug Simponi (golimumab) developed by Alvotech. This positive opinion by the CHMP paves the way for the European Commission to grant marketing authorization, potentially expanding access to the drug for patients and healthcare professionals across Europe.

Alvotech, a global biotech company focused on biosimilar medicines, announced the CHMP's recommendation on September 12, 2025. The biosimilar, known as Gobivaz, is intended for treating several chronic inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and juvenile idiopathic arthritis. The CHMP's recommendation covers two dosages (50 mg/0.5mL and 100 mg/mL) in pre-filled syringe and autoinjector forms European Medicines Agency Recommends Marketing Approval of Gobivaz®, Alvotech’s Proposed Biosimilar to Simponi® (golimumab) with Advanz Pharma as Commercialization Partner^[1].

The positive opinion from the CHMP follows successful clinical trials, including a confirmatory study in April 2024 and a pharmacokinetic study in November 2023. These studies demonstrated that AVT05 has comparable efficacy, safety, and immunogenicity profiles to the reference product, Simponi European Medicines Agency Recommends Marketing Approval of Gobivaz®, Alvotech’s Proposed Biosimilar to Simponi® (golimumab) with Advanz Pharma as Commercialization Partner^[1].

Alvotech and its marketing partner, Advanz Pharma, are working together to increase access to golimumab. The partnership leverages Alvotech's development and manufacturing capabilities with Advanz Pharma's European commercialization expertise. The recommendation positions Alvotech to capture market share in Europe's anti-TNF market, one of the largest segments in biologic therapies for autoimmune diseases European Medicines Agency Recommends Marketing Approval of Gobivaz®, Alvotech’s Proposed Biosimilar to Simponi® (golimumab) with Advanz Pharma as Commercialization Partner^[1].

The CHMP's positive recommendation for Gobivaz represents a significant regulatory milestone for Alvotech and Advanz Pharma. The European Commission typically grants marketing authorization within 67 days following a CHMP positive opinion, which could accelerate the availability of the biosimilar in the European market.

References
European Medicines Agency Recommends Marketing Approval of Gobivaz®, Alvotech’s Proposed Biosimilar to Simponi® (golimumab) with Advanz Pharma as Commercialization Partner^[1] https://www.stocktitan.net/news/ALVO/european-medicines-agency-recommends-marketing-approval-of-gobivaz-s4j3slp7c3gh.html