EMA Accepts Alvotech and Advanz Pharma's Biosimilar Candidate AVT05 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 is designed to treat chronic inflammatory conditions and marks the first global MAA filing for a Simponi biosimilar candidate.
Clinical trials have demonstrated comparable safety, efficacy, and immunogenicity between AVT05 and Simponi in treating moderate to severe rheumatoid arthritis (搜索).
The European Medicines Agency (EMA) has accepted a marketing authorisation application (MAA) for AVT05, a proposed biosimilar developed by Alvotech and Advanz Pharma (搜索) referencing Johnson & Johnson’s Simponi (golimumab). This marks a significant step toward offering a biosimilar option for patients with chronic inflammatory conditions. The approval process is expected to conclude by the fourth quarter of 2025.
Development and Clinical Trials
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, demonstrating 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.
Joseph McClellan, Alvotech's chief scientific officer, 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
Alvotech and Advanz Pharma (搜索) have expanded their strategic partnership, initially established in February 2023 with AVT23, a biosimilar to Novartis’ Xolair (omalizumab). In May 2024, the partnership grew to include five additional biosimilar candidates, including AVT05, AVT16, and three early-stage biosimilar candidates. Moreover, in June 2024, the companies entered a commercialization agreement for two biosimilar candidates to Eylea, AVT06 and AVT29, targeting different dosage presentations.
About Golimumab and TNF-alpha
Golimumab, the active ingredient in Simponi, is a monoclonal antibody that targets tumour necrosis factor-alpha (TNF alpha), a substance involved in systemic inflammation. By inhibiting TNF-alpha, golimumab helps reduce inflammation and alleviate symptoms in various autoimmune diseases. Simponi is approved for the treatment of rheumatoid arthritis (搜索), psoriatic arthritis, ankylosing spondylitis, ulcerative colitis (搜索), and Crohn's disease.
Market Context
The introduction of a biosimilar like AVT05 could provide a more cost-effective alternative to Simponi, potentially increasing patient access to this important medication. Biosimilars are designed to have the same safety and efficacy as their reference biologics, offering a valuable option for healthcare providers and patients alike.