Teva Pharmaceuticals and Alvotech have announced the US launch of the Selarsdi (ustekinumab-aekn) injection, a biosimilar to Johnson & Johnson’s Stelara (ustekinumab).
The product is indicated for the treatment of Crohn’s disease, paediatric plaque psoriasis, paediatric psoriatic arthritis, plaque psoriasis, psoriatic arthritis and ulcerative colitis.
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This marks the second biosimilar launched in the country through the strategic collaboration between the companies.
Selarsdi has been approved by the US Food and Drug Administration in four presentations, aligning with the approved presentations of the reference Stelara.
The agency has provisionally determined that Selarsdi will be interchangeable with Stelara following the exclusivity period for the first interchangeable biosimilar on 30 April 2025.
Selarsdi is available in two single-dose prefilled syringes for subcutaneous injection at 45 mg/0.5 mL and 90 mg/mL, a single-dose vial for subcutaneous injection at 45 mg/0.5 mL and a single-dose vial for intravenous infusion at 130 mg/26 mL.
Ustekinumab is a human monoclonal antibody that targets the p40 protein, which is shared by interleukin (IL)-12 and IL-23 cytokines, known to be significant in the treatment of immune-mediated and inflammatory conditions.
Teva Pharmaceuticals US Biosimilars senior vice-president Thomas Rainey stated: “The US availability of Selarsdi reinforces Teva’s overall strategy to identify strategic business partners to develop and manufacture biosimilars while leveraging Teva’s commercial presence and experience to bring this and other products to the US market.”
Alvotech developed Selarsdi using Sp2/0 cells and a continuous perfusion process, which aligns with the production methods of Stelara.
The strategic collaboration between the companies, initiated in August 2020, focused on the exclusive commercialisation of five biosimilar product candidates of Alvotech.
It was extended in July 2023 to include two additional biosimilars and new presentations of two previously collaborated products.
Alvotech deals with development and manufacturing while Teva oversees exclusive US commercialisation.
