EMA Accepts Marketing Authorization Application for Alvotech's Golimumab Biosimilar, AVT05
核心洞察
The European Medicines Agency (EMA) has accepted the Marketing Authorization Application for AVT05, a biosimilar to Simponi (golimumab), developed by Alvotech.
AVT05 is intended for treating chronic inflammatory diseases like rheumatoid arthritis (搜索), psoriatic arthritis (搜索), and ankylosing spondylitis (搜索), potentially expanding patient access to biologic medicines.
Clinical studies have demonstrated comparable efficacy, safety, and immunogenicity between AVT05 and Simponi in patients with moderate to severe rheumatoid arthritis (搜索).
Alvotech and Advanz Pharma (搜索) 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 potentially offering a more accessible treatment option for patients with chronic inflammatory diseases. The application is believed to be the first globally for a golimumab biosimilar.
The EMA's acceptance of the MAA indicates that AVT05 has met the necessary criteria for review, bringing it closer to potential approval and commercial availability in Europe. The approval process is anticipated to be completed in the fourth quarter of 2025.
Clinical Data Supporting AVT05
Alvotech previously announced positive top-line results from a confirmatory clinical study in April 2024, which compared the efficacy, safety, and immunogenicity of AVT05 to Simponi® in patients with moderate to severe rheumatoid arthritis (搜索). Furthermore, a pharmacokinetic study in November 2023 demonstrated comparable pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® in healthy adult participants.
Executive Perspectives
"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. He further noted that Alvotech's in-house capabilities in utilizing a host cell line and process similar to that used to manufacture the reference biologic provided a head start in developing the biosimilar candidate.
Nick Warwick, Chief Medical Officer of Advanz Pharma (搜索), stated, "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."
About AVT05
AVT05 is a biosimilar candidate for Simponi® and Simponi Aria® (golimumab), 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 (搜索), psoriatic arthritis (搜索), and ankylosing spondylitis (搜索). It is currently an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
Strategic Partnership
Alvotech and Advanz Pharma (搜索) initially announced a commercialization agreement for AVT23, a proposed biosimilar to Xolair® (omalizumab), in February 2023. The partnership expanded in May 2024 to include five additional biosimilar candidates developed by Alvotech, including AVT05, AVT16 (a proposed biosimilar to Entyvio® (vedolizumab)), and three additional early-stage biosimilar candidates.