On 19 September 2022, Sandoz announced positive results following its ROSALIA I/III clinical trial study for its proposed biosimilar denosumab. This follows the August announcement that Lannett Company successfully completed subject dosing in the clinical trial of its biosimilar insulin glargine.
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 . The originator product is Amgen’s Prolia/Xgeva, its patents expired in Europe on 25 June 2022 (except for France, Italy, Spain and the UK, where they will expire in 2025 ) and will expire in the US on 19 February 2025 . Amgen recorded sales of US$3.25 billion for the drug in 2021, with two thirds coming from the US market. Biosimilar developers like Sandoz’s hope to tap into this market and bring more affordable treatment options to patients.
Sandoz reported that their ROSALIA study met primary endpoints, confirming the proposed biosimilar denosumab matches Amgen’s reference product in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in postmenopausal women with osteoporosis.
This announcement comes after recent positive outcomes for Sandoz’s high concentration adalimumab biosimilar  and multiple sclerosis proposed biosimilar natalizumab  that were accepted for review by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) earlier in 2022.
Sandoz is set to separate from parent company Novartis by the end of 2023 .
Lannett’s insulin glargine
Insulin glargine is a long-acting basal insulin analogue, to help control the blood sugar level of those with diabetes. It is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above . The originator product is Sanofi’s Lantus and patents on Lantus expired in 2014 in both Europe and the US  and a number of biosimilar versions have since been approved in these and other regions.
Lannett has co-developed its insulin glargine biosimilar with its strategic alliance partners within the HEC Group of companies (HEC). No serious adverse events were reported during subject dosing and the company expects top-line data and analytics to be available later in the year. This comes following the success of a previous clinical trial reported in 2020 which showed that the biosimilar was well tolerated and matched the reference product in terms of pharmacokinetics, pharmacodynamics and safety .
Lannett anticipates filing the Biologics License Application (BLA) for a biosimilar and interchangeable insulin glargine to Lantus in the US in Spring 2023 and will potentially launch the product in the first half of 2024. It is hoped that, when approved this insulin product and its insulin aspart biosimilar, will help the company bounce back following the sizeable losses disclosed for its 2022/23 financial year.
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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of denosumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 30]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
2. 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
3. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for high concentration adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 30]. Available from: www.gabionline.net/biosimilars/news/fda-accepts-application-for-high-concentration-adalimumab-biosimilar
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 2022 Sep 30]. Available from: www.gabionline.net/biosimilars/news/applications-for-natalizumab-biosimilars-accepted-by-fda-and-ema
5. GaBI Online - Generics and Biosimilars Initiative. Novartis is set to spin-off Sandoz [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 30]. Available from: www.gabionline.net/pharma-news/novartis-is-set-to-spin-off-sandoz
6. GaBI Online - Generics and Biosimilars Initiative Biosimilars of insulin glargine [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 30]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-insulin-glargine
7. GaBI Online - Generics and Biosimilars Initiative Positive trial results for Lannett’s insulin biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 30]. Available from: www.gabionline.net/biosimilars/research/Positive-trial-results-for-Lannett-s-insulin-biosimilar
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