The European Medicines Agency (EMA) has accepted the marketing authorization application for AVT05, a biosimilar to Johnson & Johnson’s Simponi (golimumab), submitted by Alvotech and Advanz Pharma. This biosimilar is intended for the treatment of chronic inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
Simponi, a monoclonal antibody, targets and blocks tumor necrosis factor (TNF) alpha, a key inflammatory cytokine implicated in various autoimmune disorders. As a biologic drug, Simponi is associated with high costs, potentially limiting patient access. With Johnson & Johnson’s patent for Simponi set to expire in the U.S. in 2024 and in the EU in 2025, the entry of biosimilars like AVT05 could provide more affordable treatment options.
Clinical Equivalence and Development
Biosimilars are designed to mirror the efficacy and safety of their reference biologics while being more cost-effective to produce. This approach aims to broaden patient access to critical therapies, particularly for those in lower socioeconomic groups, and to alleviate financial pressures on healthcare systems. Approval hinges on demonstrating comparable efficacy, safety, pharmacokinetic profiles, and immunogenicity to the original biologic.
According to Nick Warwick, Chief Medical Officer of Advanz Pharma, the EMA’s acceptance marks "a significant step forward in expanding treatment options for patients with chronic inflammatory diseases across Europe," underscoring the company's commitment to enhancing patient access to high-quality biologic medicines.
Alvotech and Advanz Pharma entered a commercialization agreement in February 2023, initially focusing on AVT23, a potential biosimilar to Novartis’ Xolair (omalizumab). In May 2024, they expanded their collaboration to include five additional biosimilar candidates developed by Alvotech, including AVT05.
Clinical Trial Results
In April 2024, Alvotech announced positive top-line results from a confirmatory clinical study comparing AVT05 and Simponi in patients with moderate to severe rheumatoid arthritis. The study assessed the safety, efficacy, and immunogenicity of the two drugs, demonstrating their similarity.
Joseph McClellan, Chief Scientific Officer of Alvotech, commented on the EMA’s acceptance, stating, "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 in house to utilize 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."
Biosimilar Market Growth
In July 2024, Avotech and Stada Arzneimittel launched Uzpruvo, the first approved biosimilar for Johnson & Johnson’s Stelara (ustekinumab) in Europe, following the 2023 U.S. FDA approval of Amgen’s Wezlana. These approvals highlight the increasing demand for biosimilars, with the global market projected to reach nearly $44 billion by the end of 2024 and further expand by over $100 billion in the next decade.
