On 3 April 2024, China-based biopharmaceutical company Mabwell announced that their Maiweijian (denosumab) injection, developed by its wholly-owned subsidiary T-mab, obtained the marketing approval from China’s National Medical Products Administration (NMPA). This product is the first denosumab copy biologicalto receive marketing approval in China.
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 biological is osteoporosis treatment Amgen’s Prolia/Xgeva (denosumab).
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. The patent for the originator expired in China in 2022 [2].
China’s NMPA approved Maiweijian as a copy biological to Xgeva. In 2022, sales of denosumab amounted to 427 million yuan in China.
Maiweijian (120 mg) is approved to treat giant cell tumor of the bone that is unresectable or where surgical resection may lead to severe functional impairment, including in adults and adolescents with mature skeletal development. Mabwell published the results of phase I and phase III clinical studies of the denosumab biosimilar in 2022 and 2024, respectively. In the pharmacokinetic comparison studies and clinical efficacy comparison studies conducted in patients with bone metastases of solid tumours, the company comprehensively and systematically demonstrated the similarity between the Maiweijian biosimilar and the originator product in terms of pharmacokinetics, pharmacodynamics, clinical efficacy, and safety. Mabwell is now in the process of advancing marketing efforts so that Maiweijian covers all indications of the reference product.
Mabwell’s denosumab product is the first to receive marketing authorization in China. This is despite early advances made by other biosimilar producers. For example, in 2019, Chinese pharmaceutical company, Qilu Pharmaceutical announced it was carrying out a phase III clinical trial for a denosumab biosimilar (QL1206) [3]. In May 2020, China-based drugmaker Shanghai Henlius Biotech announced that the NMPA had accepted an investigational new drug application for HLX4, their denosumab copy biological [4].
Furthermore, in April 2020, China’s Center for Drug Evaluation (CDE) of the NMPA issued a guidance document on denosumab biosimilars [5]. This guidance specifies that if a systematic comparison study is carried out in a certain population, then the candidate drug may also seek approval for extrapolation of other indications with the same mechanism of action for the originator drug based on the existing data and information.
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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 16]. 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. Qilu starts phase III trial for denosumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Apr 16]. Available from:
www.gabionline.net/biosimilars/news/Qilu-starts-phase-III-trial-for-denosumab-copy-biological
4. GaBI Online - Generics and Biosimilars Initiative. China accepts IND application for denosumab copy biological HLX14 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Apr 16]. Available from: www.gabionline.net/biosimilars/news/China-accepts-IND-application-for-denosumab-copy-biological-HLX14
5. GaBI Online - Generics and Biosimilars Initiative. China publishes draft guideline for denosumab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Apr 16]. Available from: www.gabionline.net/guidelines/China-publishes-draft-guideline-for-denosumab-copy-biologicals
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