Sandoz, the generics division of Novartis, announced on 6 February 2023 that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for a proposed denosumab biosimilar (GP2411).
The submission is supported by comprehensive analytical and clinical data package, including data from the phase I/III ROSALIA study, announced on 19 September 2022 [1].
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 [2]. The originator product is Amgen’s Prolia/Xgeva (denosumab).
A brief overview of Sandoz’s biosimilar portfolio includes SOK583A1 (aflibercept) currently in phase III and a wide range of collaborations on biosimilars covering:
1. a commercialization agreement with Bio-Thera Solutions on a proposed biosimilar bevacizumab (BAT1706) in the US, Europe, Canada and selected other countries [3]
2. a global commercialization agreement with Polpharma Biologics on a proposed natalizumab biosimilar [4]
3. an agreement with EirGenix on a proposed biosimilar trastuzumab [5]
4. a supply and commercialization partnership with Gan & Lee, a leading insulin supplier headquartered in China, to bring to market biosimilar versions of glargine, lispro and aspart insulins [6]
5. a global partnership with Biocon in the area of immunology [7].
Sandoz’s denosumab biosimilar GP2411 BLA includes all the indications covered by the reference product, however, the originator product is still under patent in the US until 2025 [7].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Successful trials for Sandoz and Lannett biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 9]. Available from:
www.gabionline.net/biosimilars/research/successful-trials-for-sandoz-and-lannett-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of denosumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 9]. Available from:
www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
3. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for bevacizumab biosimilar BAT1706 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 9]. Available from:
www.gabionline.net/biosimilars/news/FDA-accepts-application-for-bevacizumab-biosimilar-BAT1706
4. GaBI Online - Generics and Biosimilars Initiative. Applications for natalizumab biosimilars accepted by FDA and EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 9]. Available from:
www.gabionline.net/biosimilars/news/applications-for-natalizumab-biosimilars-accepted-by-fda-and-ema
5. GaBI Online - Generics and Biosimilars Initiative. Sandoz and EirGenix make deal for trastuzumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 9]. Available from:
www.gabionline.net/pharma-news/Sandoz-and-EirGenix-make-deal-for-trastuzumab-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. Sandoz makes biological deal in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 9]. Available from: www.gabionline.net/pharma-news/Sandoz-makes-biological-deal-in-China
7. GaBI Online - Generics and Biosimilars Initiative. Biocon and Sandoz join forces for global next generation biosimilars[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 9]. Available from:
www.gabionline.net/pharma-news/Biocon-and-Sandoz-join-forces-for-global-next-generation-biosimilars
8. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
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