LG Chem gains approval for adalimumab biosimilar in Japan / News / Biosimilars / Home - GaBi Online

LG Chem gains approval for adalimumab biosimilar in Japan

Biosimilars/News | Posted 30/04/2021 0 Post your comment

Japan-based LG Chem (formerly LG Life Sciences) announced on 23 March 2021 in a public filing that it had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for 20 mg, 40 mg and 80 mg syringe, and 40 mg pen formulations of its adalimumab biosimilar, Adalimumab BS MA (LBAL).

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, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

Adalimumab BS MA received approval for nine indications, including rheumatoid arthritis, psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, intestinal Behçet's disease, Crohn’s disease and ulcerative colitis.

According to LG Chem, its Japanese partner Mochida Pharmaceutical has exclusive sales and marketing rights over the biosimilar in Japan. The two companies made an agreement to develop an adalimumab biosimilar back in 2014 [1] and have carried out phase III trials in both Korea and Japan.

There are already two other adalimumab biosimilars approved in Japan. The first adalimumab biosimilar to be approved in the country was adalimumab biosimilar 1 from Fujifilm Kyowa Kirin Biologics in June 2020 [2]. While Daiichi Sankyo’s adalimumab biosimilar 2 was approved by the PMDA in January 2021 [3].

Related article
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 Latinoamérica. 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. LG Life Sciences and Mochida make deal for adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 30]. Available from: www.gabionline.net/Biosimilars/News/LG-Life-Sciences-and-Mochida-make-deal-for-adalimumab-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Japanese approval for first adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 30]. Available from: www.gabionline.net/Biosimilars/News/Japanese-approval-for-first-adalimumab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 30]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Japan

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.

Source: Korea Biomed, LG Chem