In February 2025, Teva Pharmaceuticals and Alvotech announced the availability of Selardsi (ustekinumab-aekn) in the US, followed by Sandoz’s Pyzchiva (ustekinumab-ttwe). These two products are biosimilars to the originator drug, Johnson & Johnson’s Stelara (ustekinumab).
Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL 12 and IL 23 which help activate certain T cells. It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors. It is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis [1].
Selarsdi is the second Stelara biosimilar to launch in the US, following Amgen’s Wezlana (ustekinumab-auub) which was launched in January 2025, and is exclusively available through Optum, a division of UnitedHealth Group.
Approved by the US Food and Drug administration (FDA) in April 2024, Selarsdi is available in the following formulations [2]:
- 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection
- 45 mg/0.5 mL in a single-dose vial for subcutaneous injection, and
- 130 mg/26 mL in a single-dose vial for intravenous infusion
Selarsdi is being offered at an 85% discount off the wholesale acquisition cost of Stelara. Eligible patients may receive their medication at no cost or may qualify for assistance through Teva’s programs, according to a company spokesperson.
Sandoz’s Pyzchiva, developed by Samsung Bioepis, was approved in the US on 28 June 2024. The FDA approved Pyzchiva in the following formulations: 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection, and 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion [3].
Pyzchiva had already received European Commission approval on 22 April 2024 [4].
Both Selarsdi and Pyzchiva are approved for all indications of their reference medicine. The FDA has granted both products a provisional determination of interchangeability with Stelara, with exclusivity expiring on 30 April 2025. This follows the approval of the first interchangeable biosimilar – Amgen’s Wezlana (ustekinumab-auub) [5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 28]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves ustekinumab, trastuzumab, and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 28]. Available from: www.gabionline.net/biosimilars/news/fda-approves-ustekinumab-trastuzumab-and-tocilizumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves third ustekinumab biosimilar Pyzchiva [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 28]. Available from: www.gabionline.net/biosimilars/news/fda-approves-third-ustekinumab-biosimilar-pyzchiva
4. GaBI Online - Generics and Biosimilars Initiative. EC biosimilar approvals: Omlyclo, Jubbonti/Wyost, and Pyzchiva [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 28]. Available from: www.gabionline.net/biosimilars/news/ec-biosimilar-approvals-omlyclo-jubbonti-wyost-and-pyzchiva
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ustekinumab biosimilar Wezlana [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 28]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ustekinumab-biosimilar-wezlana
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