Sandoz launched Wyost/Jubbonti, the first FDA-approved denosumab biosimilars, in June 2025. In May 2025, Formycon/Fresenius Kabi and Biocon introduced ustekinumab biosimilars in Canada and Japan, offering cost-effective options for bone and inflammatory conditions.
On 2 June 2025, Sandoz announced that Wyost and Jubbonti (denosumab-bddz) are now available to patients in the US. Additionally, in May 2025, Formycon and its commercialization partner Fresenius Kabi announced the launch of Otulfi, an ustekinumab biosimilar referencing Johnson & Johnson’s Stelara, in Canada. The same month, Biocon Biologics announced that its commercial partner in Japan, Yoshindo Inc, had launched Ustekinumab BS Subcutaneous Injection [YD].
Wyost and Jubbonti (denosumab-bddz) are the first and only FDA-approved interchangeable denosumab biosimilars to Amgen’s Prolia and Xgeva, approved for all indications of the reference products.
Denosumab is a humanized monoclonal antibody that is an inhibitor of the receptor activator of nuclear factor kappa-B ligand (RANKL), which works by preventing the development of osteoclasts which are cells that break down bone. It is used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone and giant cell tumour of bone [1].
Wyost is indicated for osteoporosis treatment. A different dose of the antibody (marketed as Jubbonti) is for preventing bone problems in multiple myeloma patients and those whose solid tumours have metastasized to the bones [2].
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 [3].
Following Health Canada’s approval in December 2024, Otulfi is now available as a high-quality and cost-effective treatment for adults with moderate-to-severe Crohn’s disease, ulcerative colitis, plaque psoriasis, or psoriatic arthritis. The biosimilar is already marketed in the US and Europe [4].
In Japan, Biocon Biologic’s ustekinumab biosimilar is commercialized by Yoshindo Inc as Ustekinumab BS Subcutaneous Injection [YD]. The product, approved in the US and Europe, is marketed there as Yesintek [5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of denosumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jul 10]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
2. GaBI Online - Generics and Biosimilars Initiative. First denosumab biosimilars approved in Canada and the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jul 10]. Available from: www.gabionline.net/biosimilars/news/first-denosumab-biosimilars-approved-in-canada-and-the-us
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jul 10]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
4. GaBI Online - Generics and Biosimilars Initiative. Ustekinumab biosimilars Yesintek, SteQeyma, and Otulfi approved by FDA, EMA and Health Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jul 10]. Available from: www.gabionline.net/biosimilars/news/ustekinumab-biosimilars-yesintek-steqeyma-and-otulfi-approved-by-fda-ema-and-health-canada
5. 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 10]. Available from: www.gabionline.net/biosimilars/general/the-ustekinumab-shift-biosimilars-displace-stelara-s-market-leadership
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