EMA Greenlights Marketing Authorization Application from Alvotech and Advanz Pharma for J&J’s Simponi Biosimilar
The European Medicines Agency (EMA) has given the green light to Alvotech and Advanz Pharma for their marketing authorization submission relating to AVT05, a biosimilar targeting Johnson & Johnson’s Simponi (golimumab), which is employed in the medical treatment of chronic inflammatory conditions such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
Simponi is based on a monoclonal antibody that effectively inhibits tumor necrosis factor (TNF) alpha, a key inflammatory cytokine linked to numerous autoimmune disorders. However, being a biologic, Simponi carries a high price tag. To this point, no biosimilars for Simponi are available on the global market. The patent on Simponi held by Johnson & Johnson is expiring in the United States in 2024 and in the European Union in 2025, marking a potential opening for biosimilar developers.
The concept behind biosimilars is that, while they function similarly to the original branded biologic, they can often be produced at a lower cost. This approach aims to enhance patient access to essential or life-saving treatments, particularly for those in lower-income brackets, and to alleviate the financial burdens on healthcare systems. Upon approval, a biosimilar must demonstrate comparable efficacy, safety, pharmacokinetics, and immunogenicity to the reference product.
Nick Warwick, Chief Medical Officer of Advanz Pharma, stated, “The EMA’s acceptance of the AVT05 application marks a major advancement in broadening treatment opportunities for individuals with chronic inflammatory conditions throughout Europe.” He emphasized their commitment to enhancing patient access to high-quality biologic therapies.
Alvotech, a global biotechnology firm, formed a commercialization partnership with UK-based Advanz Pharma in February 2023 to focus on AVT23, a prospective biosimilar of Novartis’ Xolair (omalizumab). This biologic is utilized in treating moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria. In May 2024, their collaboration expanded to include five additional biosimilar candidates developed by Alvotech, including AVT05.
April 2024 brought positive preliminary results from a confirmatory clinical trial analyzing AVT05 against Simponi in patients suffering from moderate to severe rheumatoid arthritis, focusing on safety, efficacy, and immunogenic response.
Joseph McClellan, Chief Scientific Officer of Alvotech, remarked on the EMA’s approval, stating, “This marks a significant milestone for us, our partners, and the patient community, as we move closer to providing access to a biosimilar of Simponi. With the in-house capabilities and expertise in utilizing the same host cell line and processes used for the reference biologic, we have gained a critical advantage in developing a biosimilar for Simponi.”
In July 2024, Avotech and German pharmaceutical firm Stada Arzneimittel revealed the EMA’s endorsement of Uzpruvo, which is the first approved biosimilar for Johnson & Johnson’s Stelara (ustekinumab) in the European market. This announcement followed the 2023 approval by the U.S. FDA of Amgen’s Wezlana, recognized as the first biosimilar for ustekinumab.
These recent approvals highlight the surging interest in biosimilars. As the approval rates continue to rise globally, the biosimilar market is witnessing significant growth. Projections suggest it will approach a value of nearly billion by the end of 2024, with an anticipated increase of over 0 billion over the next decade.