On 13 November 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions positive opinions recommending the granting of a marketing authorization for two biosimilar medicines: Ondibta (insulin glargine), for the treatment of diabetes mellitus; and Osqay (denosumab), for the treatment of osteoporosis and bone loss.
Insulin glargine biosimilar Ondibta
Beijing-based Gan & Lee Pharmaceuticals’ insulin glargine biosimilar Ondibta will be available as a 100 units/mL solution for injection (pre-filled pen).
The active substance of Ondibta is insulin glargine, a long-acting insulin analogue [1]. The originator product is Sanofi’s Lantus.
Ondibta is Gan & Lee’s first and only China-developed insulin glargine product to complete head-to-head Phase III clinical studies against Sanofi's Lantus in both Europe and the US. Theses pivotal studies, involving over 1,100 patients with diabetes (approximately 570 with T1DM and 580 with T2DM), demonstrated therapeutic biosimilarity in efficacy and safety.
Additionally, using the gold-standard glucose clamp technique, Gan & Lee conducted a head-to-head study comparing its insulin glargine U300 with the reference product Toujeo, confirming their biosimilarity in efficacy and safety.
Upon approval by the European Commission, Ondibta will be available for markets across the European Union (EU), Iceland, Liechtenstein, and Norway.
Denosumab biosimilar Osqay
Theramex Ireland’s denosumab biosimilar Osqay will be available as a 60 mg solution for injection in pre-filled syringes. Osqay is approved for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment of bone loss associated with hormone ablation in men with prostate cancer and treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients.
The active substance of Osqay is denosumab, a drug for the treatment of bone diseases [2]. The originator product is Amgen’s Prolia.
In June 2021, Theramax UK signed a license and supply agreement with Enzene Biosciences Limited, based in Pune, India, for the registration and commercialisation of a denosumab biosimilar to Prolia [3].
Separately, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for denosumab biosimilars Bildyos (injection 60 mg/mL ) and Bilprevda (injection 120 mg/1.7 mL), which are biosimilars to Prolia and Xgeva, respectively, for all indications of the reference products.
Related articles
New insulin glargine and potential adalimumab interchangeable biosimilars
Orion-CuraTeQ and Theramax-Enzene Biosciences partnerships
References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab and insulin glargine biosimilars Yusimry and Rezvoglar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jan 16]. Available from: www.gabionline.net/biosimilars/news/fda-approves-adalimumab-and-insulin-glargine-biosimilars-yusimry-and-rezvoglar
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of denosumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jan 16]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
3. GaBI Online - Generics and Biosimilars Initiative. Theramex to market Prolia biosimilar in Europe and Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jan 16]. Available from: www.gabionline.net/pharma-news/theramex-to-market-prolia-biosimilar-in-europe-and-australia
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