EMA Accepts Alvotech and Advanz Pharma's Biosimilar AVT05 Application for Simponi
核心洞察
The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for AVT05, a biosimilar to Johnson & Johnson’s Simponi (golimumab).
AVT05 represents the first global MAA filing for a biosimilar candidate targeting Simponi, a biologic drug used in treating chronic inflammatory conditions.
Clinical trials have demonstrated comparable safety, efficacy, and immunogenicity between AVT05 and Simponi in treating moderate to severe rheumatoid arthritis (搜索).
Alvotech and Advanz Pharma (搜索) have achieved a significant milestone with the European Medicines Agency (EMA) accepting their marketing authorisation application (MAA) for AVT05, a proposed biosimilar to Johnson & Johnson’s Simponi (golimumab). This marks the first global MAA filing for a biosimilar candidate to Simponi, a crucial biologic drug used in the treatment of chronic inflammatory conditions. The potential approval of AVT05 could offer a more accessible and cost-effective treatment option for patients suffering from these conditions.
Development and Clinical Data
AVT05 is being developed as a biosimilar to both Simponi and Simponi Aria (golimumab). Alvotech announced positive top-line results from a confirmatory trial in April 2024, showcasing comparable safety, efficacy, and immunogenicity between AVT05 and Simponi in treating moderate to severe rheumatoid arthritis (搜索). Furthermore, in November 2023, Alvotech released positive topline results from a pharmacokinetic study comparing AVT05 to Simponi in healthy adults, reinforcing the biosimilar's similarity to the reference product.
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. We believe having the capability and know-how inhouse to utilise 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."
Strategic Partnership and Future Prospects
This development builds upon the initial commercialisation agreement between Alvotech and Advanz Pharma (搜索) in February 2023 for AVT23, a biosimilar to Novartis’ Xolair (omalizumab). The partnership expanded in May 2024 to include five additional biosimilar candidates, including AVT05, AVT16, and three early-stage biosimilar candidates. In June 2024, both companies entered a commercialisation agreement for two biosimilar candidates to Eylea, AVT06 and AVT29, targeting different dosage presentations.
The approval process for AVT05 is expected to conclude by the fourth quarter of 2025. Golimumab, the active ingredient in Simponi, is a monoclonal antibody that targets tumour necrosis factor-alpha (TNF alpha), a substance involved in systemic inflammation. Simponi is prescribed for various chronic inflammatory conditions, including rheumatoid arthritis (搜索), psoriatic arthritis, ankylosing spondylitis, ulcerative colitis (搜索), and Crohn's disease. The introduction of a biosimilar could significantly reduce healthcare costs and improve patient access to this important medication.