EMA Review of AVT05 Biosimilar to Simponi® Marks Major Step for Alvotech & Advanz Pharma

Alvotech and Advanz Pharma have taken a significant step forward with the European Medicines Agency (EMA) now reviewing Alvotech’s AVT05, a biosimilar to Simponi® (golimumab), used for chronic inflammatory conditions. If approved, AVT05 will expand treatment options across Europe and strengthen Alvotech’s position in the biosimilar market.

This announcement follows Alvotech's successful clinical trials showing AVT05’s efficacy, safety, and tolerability comparable to Simponi®. Through strategic partnership, both companies aim to deliver affordable treatment alternatives, further evidenced by additional biosimilar projects targeting Xolair® and Eylea®.

Advanz Pharma’s Chief Medical Officer, Nick Warwick, highlighted the collaboration’s commitment to making quality biologics accessible. The EMA’s decision is expected in late 2025, with AVT05 potentially bringing a cost-effective option to patients battling inflammatory diseases.