FDA approves denosumab biosimilars Osvyrti and Jubereq, Boncresa and Oziltus

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FDA approves denosumab biosimilars Osvyrti and Jubereq, Boncresa and Oziltus

Biosimilars/News | Posted 07/01/2026 0 Post your comment

The US Food and Drug Administration (FDA) approved four denosumab biosimilars in late 2025. The first two, Osvyrti and Jubereq (denosumab-desu), were approved on 29 October 2025, and reference Amgen’s Prolia and Xgeva, respectively. The second pair, Boncresa and Oziltus (denosumab-mobz), were approved on 22 December 2025, and also reference Prolia and Xgeva.

Osvyrti and Jubereq (denosumab-desu) are developed and commercialized by Accord Biopharma, the specialty division of Intas Pharmaceuticals, Ltd. Boncresa and Oziltus (denosumab-mobz) are from Amneal Pharmaceuticals and mAbxience, the latter being a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma.

The approval of Osvyrti and Jubereq was supported by two clinical trials. A Phase I pharmacokinetic (PK) study in healthy adult males demonstrated comparable PK parameters between Jubereq and Xgeva. A Phase III study in postmenopausal women with osteoporosis found Osvyrti to be highly similar to Prolia, with no clinically meaningful differences in pharmacokinetics, pharmacodynamics, safety, or efficacy.

The dual approvals mark Accord BioPharma's fourth and fifth biosimilars, demonstrating the company's continued growth in the US market. This expansion includes its assumption of US commercial operations for the Udenyca (pegfilgrastim-cbqv) franchise in early 2025 [1]. Accord's biosimilar portfolio also includes Imuldosa (ustekinumab-srlf) [2], referencing Stelara, and Hercessi (trastuzumab-strf), referencing Herceptin [3].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Coherus exits the biosimilars market with sale of Udenyca to Intas Pharmaceuticals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jan 7]. Available from: www.gabionline.net/pharma-news/coherus-exits-the-biosimilars-market-with-sale-of-udenyca-to-intas-pharmaceuticals
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves fifth ustekinumab biosimilar Imuldosa [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jan 7]. Available from: www.gabionline.net/biosimilars/news/fda-approves-fifth-ustekinumab-biosimilar-imuldosa
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves fifth ustekinumab biosimilar Imuldosa [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jan 7]. Available from: www.gabionline.net/biosimilars/news/fda-approves-fifth-ustekinumab-biosimilar-imuldosa

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