EMA accepts Alvotech and Advanz Pharma’s Marketing Authorization Application for biosimilar of J&J’s Simponi

The European Medicines Agency (EMA) has accepted Alvotech and Advanz Pharma’s marketing authorization application for AVT05, a biosimilar to Johnson & Johnson’s biologic Simponi (golimumab), which is used for the treatment of chronic inflammatory diseases, such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

Simponi consists of a monoclonal antibody that targets and blocks tumor necrosis factor (TNF) alpha, an inflammatory cytokine known to be involved in several autoimmune diseases. However, as a biologic, Simponi is an expensive drug. To date, there is no biosimilar to Simponi on the global market. However, Johnson & Johnson’s patent for Simponi is set to expire in 2024 in the U.S. and in 2025 in the EU, which is when developers of biosimilars can swoop​ in.

The idea behind biosimilars is that while they work similarly to the parent drug (the brand-name biologic), they are usually cheaper to produce. Developers of biosimilars thereby hope to increase patient access to life-changing or life-saving treatments, particularly for patients from lower socioeconomic groups, as well as reduce the financial load on healthcare systems. The approval of a biosimilar requires that it shows the same or very similar efficacy, safety, pharmacokinetic profile, and immunogenicity as the parent product.

“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,” explained Nick Warwick, Chief Medical Officer of Advanz Pharma in a press release. “We are committed to improving patient access to high-quality biologic medicines.”

The global biotech company Alvotech and UK-headquartered, global pharmaceutical company, Advanz Pharma entered into a commercialization agreement in February 2023. The idea was to work on AVT23, a potential biosimilar to Novartis’ Xolair (omalizumab), a biologic for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, food allergy, and chronic spontaneous hives. However, in May 2024, the companies agreed to expand their strategic collaboration to a further five biosimilar candidates developed by Alvotech, including AVT05.

Positive top-line results from a confirmatory clinical study comparing AVT05 and Simponi in patients with moderate to severe rheumatoid arthritis were announced in April 2024. The study observed the safety, efficacy, and immunogenicity between the two drugs.

Speaking of the EMA’s acceptance of their marketing authorization application, Joseph McClellan, Chief Scientific Officer of Alvotech said in a press statement: "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 in house to utilize 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."

In July 2024, Avotech and German pharma company Stada Arzneimittel announced​ the EMA approval of Uzpruvo, the first approved biosimilar for Johnson & Johnson’s Stelara (ustekinumab) in Europe. It followed the 2023 U.S. FDA approval of Amgen’s Wezlana, the first biosimilar of ustekinumab.

These approvals reflect the increasing demand for biosimilars. With growing approval rates worldwide, the global biosimilar market is booming​. By the end of 2024, it is expected to reach a size of almost $44 billion and is estimated to grow by more than $100 billion in the next decade.