On 21 February 2025, Alvotech and Teva announced the US launch of Selarsdi® (AVT04, ustekinumab-aekn for injection), biosimilar to J&J/Janssen’s Stelara®.
This follows Alvotech’s and Teva’s US ustekinumab settlement with Johnson & Johnson in June 2023, which permitted US launch of the biosimilar from 21 February 2025. Selarsdi® is now the second biosimilar available in the US, following the launch of Amgen’s Wezlana® in January 2025 through Optum Health Solution’s private label subsidiary Nuvaila.
Selarsdi® was first approved by the FDA in April 2024 in 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection for treating psoriatic arthritis and plaque psoriasis. In October 2024, the FDA approved an additional presentation for 130 mg/26 ml in a single-dose vial for intravenous infusion and expanded the label to include treatment of adults with Crohn’s disease and ulcerative colitis.
The FDA has granted Selarsdi® a provisional determination of interchangeability following the expiry of exclusivity for Wezlana® (the first interchangeable biosimilar) on 30 April 2025.
Selarsdi® was developed by Alvotech and is commercialised by Teva in the US, pursuant to an August 2020 strategic partnership between the companies for the exclusive commercialisation of five of Alvotech’s biosimilar product candidates. The partnership was expanded in July 2023 to include four additional products.