Partners Alvotech and Teva announced that the FDA has accepted their 351(k) application for AVT05, a biosimilar candidate to compete with the reference product Simponi. Golimumab is a TNF-alpha inhibiting antibody, and the reference manufacturer is Johnson & Johnson.
This first golimumab biosimilar drug application covers both the standard Simponi and Simponi Aria forms, which is approved to treat moderate-to-severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and moderate-to-severe ulcerative colitis. Simponi is available as a subcutaneous injection or intravenous infusion (Symponi Aria).
Alvotech and Teva’s application includes the top-line results of a phase 3 confirmatory trial in patients with rheumatoid arthritis. AVT05 is one of nine products that will be commercialized by the partners, in which Alvotech develops and manufactures, while Teva markets.
“This is a significant step towards being able to offer U.S. patients access to biosimilar golimumab,” said Joseph McClellan, Chief Scientific Officer of Alvotech. “Our in-house capability allowing us to match the cell line and process used to manufacture the reference biologic, has given us an important head start in developing a biosimilar candidate to Simponi and Simponi Aria for global markets.”
For 2024, US sales of the Simponi franchise was $1.1 billion (a 3.8% drop for the second consecutive year). Simponi is likely facing strong price and utilization pressure from adalimumab and its biosimilars as well as competition from other autoimmune biologic classes. Additional golimumab biosimilar competition may be limited: Only Bio-Thera Solutions has publicly disclosed a golimumab biosimilar in its pipeline.
