EMA Accepts Alvotech's Biosimilar Golimumab (AVT05) Application for Review
核心洞察
The European Medicines Agency (EMA) has accepted Alvotech's Marketing Authorization Application for AVT05, a biosimilar to Simponi® (golimumab).
AVT05 is intended for treating chronic inflammatory diseases, marking the first global filing for a golimumab biosimilar.
Alvotech anticipates the EMA's review process will conclude in the fourth quarter of 2025, potentially expanding treatment options in Europe.
The European Medicines Agency (EMA) has accepted a Marketing Authorization Application (MAA) for AVT05, Alvotech's proposed biosimilar to Simponi® (golimumab). This marks a significant step toward expanding treatment options for chronic inflammatory diseases in Europe. Alvotech, in partnership with Advanz Pharma (搜索), anticipates the EMA's review process will be completed in the fourth quarter of 2025.
Alvotech's 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®." He also noted that utilizing a host cell line and process similar to the reference biologic provided a head start in developing AVT05.
Advanz Pharma (搜索)'s Chief Medical Officer, Nick Warwick, 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. We are committed to improving patient access to high-quality biologic medicines."
Clinical Trial Data
In April 2024, Alvotech announced 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 (搜索). The results demonstrated comparable outcomes between the biosimilar and the reference product.
Prior to this, in November 2023, Alvotech reported positive topline results from a pharmacokinetic study. This study assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® in healthy adult participants, further supporting the biosimilarity of AVT05.
About AVT05
AVT05 is a biosimilar candidate to golimumab, a biologic medicine used to treat several chronic inflammatory diseases, including rheumatoid arthritis (搜索), psoriatic arthritis (搜索), ankylosing spondylitis (搜索), ulcerative colitis (搜索), and Crohn's disease (搜索). Golimumab functions as a TNF-alpha (搜索) inhibitor, reducing inflammation by blocking the activity of tumor necrosis factor-alpha (TNF-α).
Broader Pipeline
Alvotech and Advanz Pharma (搜索) have an existing partnership that includes AVT23, a proposed biosimilar to Xolair® (omalizumab), and AVT16, a proposed biosimilar to Entyvio® (vedolizumab). The partnership was expanded to include five additional biosimilar candidates being developed by Alvotech, including AVT05, AVT16, and three undisclosed early-stage biosimilar candidates.
Market Context
The introduction of biosimilars like AVT05 aims to provide more affordable treatment options for patients with chronic inflammatory conditions. Simponi® is a registered trademark of Johnson & Johnson. Entyvio® is a trademark of Millennium Pharmaceuticals, Inc. Xolair® is a registered trademark of Novartis AG.