Johnson & Johnson (J&J) has settled with Teva and Alvotech over the biosimilar to its most lucrative asset, Stelara. The deal allows AVT04 to enter the US market no later than February 2025. This follows a May 2023 agreement with Amgen over ABP 654, which will hit markets no later than January 1, 2025. Stelara is a human IgG1k monoclonal antibody that targets the IL-12 and IL-23 cytokines. Its patent protections will start to expire in September 2023, after which biosimilars could enter the US market and eat away at its profits. J&J's settlements could be an attempt to stall this eventuality and help it achieve its $57bn sales goal by 2025.
The biologic won its first approval in September 2009 for the treatment of moderate to severe plaque psoriasis. Stelara has since picked up several other indications in the inflammatory diseases space, most recently in August 2022 for active psoriatic arthritis in pediatric patients. However, Stelara’s patent protections will start to expire in September 2023, after which biosimilars could enter the US market and eat