On 22 October 2024, Alvotech and Teva announced US FDA approval of an additional presentation of Selarsdi™ (ustekinumab), biosimilar to Janssen’s Stelara®. The additional presentation covers Selarsdi™ 130 mg/26 ml in a single-dose vial for intravenous infusion and expands the label to include treatment of adults with Crohn’s disease and ulcerative colitis.
This announcement follows the FDA’s previous approval in April 2024 for Selarsdi™ 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection, for both adult and paediatric use.
Selarsdi™ was developed by Alvotech and will be commercialised by Teva in the United States, pursuant to an August 2020 strategic partnership between the companies for the exclusive commercialisation of five of Alvotech’s biosimilar product candidates, including Selarsdi™. The partnership was expanded in July 2023 to include additional products.
Selarsdi™ can be launched in the US from 21 February 2025, following Alvotech’s and Teva’s ustekinumab settlement with Johnson & Johnson in June 2023 and the parties have confirmed that US launch for all indications is expected in Q1/2025.