On 22 May 2025, the US Food and Drug Administration (FDA) approved Bio-Thera Solutions’ Starjemza (ustekinumab-hmny), a biosimilar ustekinumab referencing Janssen/Johnson & Johnson’s Stelara.
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].
Starjemza/BAT2206 (ustekinumab-hmny) is indicated for Crohn’s disease, juvenile plaque psoriasis, juvenile psoriatic arthritis, plaque psoriasis, psoriatic arthritis, and ulcerative colitis. It will be available in 45 mg/0.5 mL and 130 mg/26 mL vials for subcutaneous injection.
The FDA approved Starjemza/BAT2206 based on Bio-Thera’s comprehensive analytical, non-clinical, and clinical data. Extensive characterization confirmed biosimilarity to US/EU Stelara in structural, physicochemical, and biological properties. A Phase I study in healthy volunteers compared pharmacokinetics, safety, and immunogenicity between Starjemza and Stelara, while a Phase III trial in moderate-to-severe plaque psoriasis patients demonstrated comparable efficacy, safety, and immunogenicity. The evidence confirmed Starjemza’s similarity to the reference product.
This is Bio-Thera’s third biosimilar product approved in the US. The other two are Tofidence/BAT1806 (tocilizumab-bavi) [2], marketed by Biogen, and Avzivi (bevacizumab-tnjn) [3], marketed by Sandoz, approved in 2024 and 2021 respectively.
Bio-Thera and Hikma entered into a license and commercialization agreement for Starjemza in August 2021. Under the agreement, Bio-Thera is responsible for development and manufacturing, while Hikma handles commercialization in the US.
The FDA has now approved eight ustekinumab biosimilars (including Starjemza); the competition is intense [4].
There were no biosimilars approved by the FDA in June 2025.
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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 Jul 22]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
2. GaBI Online - Generics and Biosimilars Initiative. EC approvals of four biosimilars: Tofidence, Wezenla, Avzivi and SteQeyma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jul 22]. Available from: www.gabionline.net/biosimilars/news/ec-approvals-of-four-biosimilars-tofidence-wezenla-avzivi-and-steqeyma
3. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for bevacizumab biosimilar BAT1706 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jul 22]. Available from: www.gabionline.net/biosimilars/news/FDA-accepts-application-for-bevacizumab-biosimilar-BAT1706
4. GaBI Online - Generics and Biosimilars Initiative. The ustekinumab shift: biosimilars displace Stelara’s market leadership [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jul 22]. Available from: www.gabionline.net/biosimilars/general/the-ustekinumab-shift-biosimilars-displace-stelara-s-market-leadership
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