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 tumor 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 1 and phase 3 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 tumors, 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.
Related articles
China approves tocilizumab copy biological BAT1806
Copy biologicals approved in China
|
LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View the latest headline article: Se lanza la Estrategia de Certidumbre Regulatoria para biosimilares en México Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.
FORO LATINOAMERICANO
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Ver el último artículo de cabecera: Se lanza la Estrategia de Certidumbre Regulatoria para biosimilares en México !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.
|
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
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2024 Pro Pharma Communications International. All Rights Reserved.
1
Post your comment