China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 7 December 2020 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had approved its adalimumab copy biological HLX03.
Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.
HLX03 has been approved by the NMPA for the treatment of rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis in China and is the first product from Henlius to be approved for the treatment of autoimmune diseases.
Henlius reported that during the development process of HLX03, the company ‘strictly followed the NMPA’s guidelines’ and has carried out ‘multiple head-to-head comparisons between HLX03 and reference adalimumab’. The company added that ‘results from analytical studies, non-clinical studies and clinical studies showed that HLX03 is highly similar to reference adalimumab in terms of quality, safety and efficacy’.
HLX03 is the third monoclonal antibody (mAb) developed by Henlius to be approved in China. The company has also gained NMPA approval for its rituximab biosimilar Hanlikon (HLX01), the first China-developed copy biological following the new guidelines [1, 2], and for its trastuzumab biosimilar HLX02.
HLX02, which has the brand name Zercepac in Europe, was approved in Europe in July 2020, making it the first China-developed mAb biosimilar to be approved in the region [3].
Wanbang Biopharma, which is a subsidiary of Fosun Pharma and has been in the field of rheumatology for many years, will be responsible for the commercialization of HLX03 in China.
Related articles
Copy biological approvals in China, compared to the US and EU
Copy Biologicals approved in China
Biosimilars of adalimumab
| LATIN AMERICAN FORUM – Coming soon! To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America. Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM – Próximamente! Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latin América. Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.
|
References
1. GaBI Online - Generics and Biosimilars Initiative. China approves rituximab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 8]. Available from: www.gabionline.net/Biosimilars/News/China-approves-rituximab-copy-biological
2. GaBI Online - Generics and Biosimilars Initiative. Chinese guidelines for copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 8]. Available from: www.gabionline.net/Guidelines/Chinese-guidelines-for-copy-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Zercepac [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 8]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Zercepac
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 © 2021 Pro Pharma Communications International. All Rights Reserved.
0
Post your comment