First denosumab biosimilars approved in Canada and the US

The first and only denosumab biosimilars for osteoporosis and increasing bone mass were approved in Canada and the US in February and March 2024.

Sandoz announced that its denosumab biosimilar, Jubbonti and Wyost, received marketing authorization from Health Canada on 20 February and 4 March 2024, respectively. Subsequently, on 5 March 2024, the company announced that the US Food and Drug Administration (FDA) approved the two biosimilar denosumab denosumab-bddz, Jubbonti and Wyost, for all indications of the reference medicines, Amgen’s Prolia and Xgeva. These are the first and only denosumab biosimilars for osteoporosis and increasing bone mass approved in Canada and the US.

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].

The originator product is Amgen’s Prolia/Xgeva (denosumab). This is marketed as Prolia for the treatment of osteoporosis. A different dose of the antibody is marketed as Xgeva for preventing bone problems in multiple myeloma patients and those whose solid tumours have metastasized to the bones.

FDA approved Jubbonti injection as an interchangeable biosimilar to US-licensed Prolia, and Wyost injection as an interchangeable biosimilar to US-licensed Xgeva. The approval for Jubbonti and Wyost is the same for Health Canada, with the exception that it does not have the distinction of an interchangeable biosimilar as in the US.

Health Canada approval based on Phase I and Phase III clinical studies. The FDA approval is based on clinical studies and accompanied by labelling with safety warnings. The Jubbonti approval is also accompanied by approval of Sandoz’s Jubbonti Risk Evaluation and Mitigation Strategy (REMS) programme.

In Canada and the US, Jubbonti will be available as a 60 mg/mL solution in single-use prefilled syringe for subcutaneous injection, and Wyost will be available in 120 mg/1.7 mL (70 mg/mL) solution delivered as a subcutaneous injection every four weeks.

Jubbonti is approved for the osteoporosis indication and Wyost is approved for the prevention of bone-related complications from cancer,

Jubbonti and Wyost marks Sandoz Canada's eighth approved biosimilars, while Sandoz US has a total of seven biosimilars approved. For a comprehensive overview of Sandoz's biosimilars approved in both Canada and the US, please refer to Table 1 [2, 3].

Table 1: Sandoz biosimilars approved in Canada and the US*
Product name	Active substance	Authorization date*	Company name
Erelzi	etanercept	3 Aug 2017	Sandoz Canada
Erelzi (etanercept-szzs)	etanercept	30 Aug 2016	Sandoz USA
Hyrimoz	adalimumab	4 Nov 2020	Sandoz Canada
Hyrimoz (adalimumab-adaz)	adalimumab	30 Oct 2018	Sandoz USA
Inclunox	enoxaparin	5 Nov 2020	Sandoz Canada
Jubbonti	denosumab	20 Feb 2024	Sandoz Canada
Jubbonti (denosumab-bddz)	denosumab	5 Mar 2024	Sandoz USA
Omnitrope	somatropin	20 Apr 2009	Sandoz Canada
Riximyo	rituximab	28 Apr 2020	Sandoz Canada
Tyruko (natalizumab-sztn)	natalizumab	25 Aug 2023	Sandoz USA
Wyost	denosumab	4 Mar 2024	Sandoz Canada
Wyost (denosumab-bddz)	denosumab-bddz	5 Mar 2024	Sandoz USA
Zarxio (filgrastim-sndz)	filgrastim	6 Mar 2015	Sandoz USA
Ziextenzo	pegfilgrastim	21 Apr 2020	Sandoz Canada
Ziextenzo (pegfilgrastim-bmez)	pegfilgrastim	4 Nov 2019	Sandoz USA
*Data updated 3 April 2024

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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 2024 Apr 3]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Apr 3]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Apr 3]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US

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