EMA Accepts Marketing Application for Alvotech's Golimumab Biosimilar, AVT05
Key Insights
The European Medicines Agency (EMA) has accepted the Marketing Authorization Application for AVT05, a proposed biosimilar to Simponi® (golimumab), used to treat chronic inflammatory diseases.
AVT05 is the first biosimilar candidate to Simponi® to have a marketing authorization application filed globally, with potential approval expected in Q4 2025.
Clinical studies have demonstrated comparable efficacy, safety, and immunogenicity between AVT05 and Simponi® in patients with moderate to severe rheumatoid arthritis (search).
Alvotech and Advanz Pharma (search) announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for AVT05, a proposed biosimilar to Simponi® (golimumab). This marks a significant step toward expanding treatment options for patients with chronic inflammatory diseases. The application is believed to be the first global filing for a biosimilar candidate to golimumab, with potential approval anticipated in the fourth quarter of 2025.
Clinical Development and Study Results
AVT05's MAA is supported by positive top-line results from a confirmatory clinical study. The study compared the efficacy, safety, and immunogenicity of AVT05 to Simponi® in patients with moderate to severe rheumatoid arthritis (search). Additionally, a pharmacokinetic study in healthy adult participants demonstrated comparable pharmacokinetics, safety, and tolerability between AVT05 and Simponi®.
Mechanism of Action and Therapeutic Target
Golimumab, the reference product for AVT05, is a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF alpha). Elevated TNF alpha levels are implicated in several chronic inflammatory diseases, including rheumatoid arthritis (search), psoriatic arthritis (search), and ankylosing spondylitis (search). By targeting TNF alpha, golimumab helps reduce inflammation and alleviate symptoms in these conditions.
Strategic Partnership and Future Prospects
Alvotech and Advanz Pharma (search) have an existing commercialization agreement for AVT23, a proposed biosimilar to Xolair® (omalizumab). The partnership expanded to include AVT05, AVT16 (a proposed biosimilar to Entyvio®), and three additional early-stage biosimilar candidates. This collaboration aims to leverage Alvotech's development capabilities and Advanz Pharma's commercial expertise to improve patient access to high-quality biologic medicines.
Company Statements
"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®," said Joseph McClellan, Chief Scientific Officer of Alvotech. Nick Warwick, Chief Medical Officer of Advanz Pharma (search), added, "The EMA’s acceptance of the application for AVT05 represents a significant step forward in expanding treatment options for patients with chronic inflammatory diseases across Europe."