In January 2023, Bio-Thera Solutions announced that the China National Medical Products Administration (NMPA) approved BAT1806, a biosimilar of Actemra (tocilizumab), in China. This is the world’s first tocilizumab copy biological/biosimilar to be approved.
Tocilizumab is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). It is an immunosuppressive drug used mainly for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis, a severe form of arthritis in children. In Japan, tocilizumab is also approved for the treatment of Castleman’s disease, a rare benign tumour of B cells [1].
The originator product, Roche’s Actemra/RoActemra (tocilizumab), was approved by the US Food and Drug Administration (FDA) on 8 January 2010 and on 16 January 2009 by the European Medicines Agency (EMA) [1]. Tocilizumab was approved in Japan for Castleman’s disease in June 2005. Actemra/RoActemra had worldwide sales of CHF 1.4 billion (US$1.4 billion) in 2015.
Bio-Thera announced positive phase III data for BAT1806 in June 2021, demonstrating equivalent efficacy and comparable safety to the originator in patients with moderate-to-severe rheumatoid arthritis [2]. In November 2021, China’s NMPA accepted Bio-Thera’s marketing authorization application for BAT1806 [3].
Bio-Thera stated that BAT1806 is the first tocilizumab biosimilar approved by the NMPA or any other regulatory agency around the world and has been approved for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis and cytokine release syndrome. BAT1806 is Bio-Thera Solutions’ third biosimilar to receive regulatory approval by the NMPA.
Bio-Thera is developing several additional biosimilar products for the global market. These include golimumab [4], ustekinumab [5], mepolizumab and secukinumab biosimilars [6].
Related articles
Chinese biosimilars (copy biological) in European markets
China approves three bevacizumab copy biologicals
China approving more copy biologicals since new guidelines introduced
Patent expiries may drive development of copy biologicals 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: La adopción exitosa de biosimilares en Europa y EE. UU. 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: La adopción exitosa de biosimilares en Europa y EE. UU. !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 tocilizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 16]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-tocilizumab
2. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for tocilizumab biosimilar Bat1806 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 16]. Available from: www.gabionline.net/biosimilars/research/positive-phase-iii-results-for-tocilizumab-biosimilar-bat1806
3. GaBI Online - Generics and Biosimilars Initiative. China accepts Bio-Thera’s application for tocilizumab copy biological BAT1806 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 16]. Available from:
www.gabionline.net/biosimilars/news/china-accepts-bio-thera-s-application-for-tocilizumab-copy-biological-bat1806
4. GaBI Online - Generics and Biosimilars Initiative. Clinical trials begin for Bio-Thera’s golimumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 16]. Available from:
www.gabionline.net/biosimilars/research/clinical-trials-begin-for-bio-thera-s-golimumab-copy-biological
5. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera and Samsung Bioepis start clinical trials for ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 16]. Available from:
www.gabionline.net/biosimilars/news/bio-thera-and-samsung-bioepis-start-clinical-trials-for-ustekinumab-biosimilars
6. GaBI Online - Generics and Biosimilars Initiative. Advances for Bio-Thera’s secukinumab and mepolizumab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 16]. Available from:
www.gabionline.net/biosimilars/news/advances-for-bio-thera-s-secukinumab-and-mepolizumab-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 © 2023 Pro Pharma Communications International. All Rights Reserved.
0
Post your comment