LG Chem gains approval for adalimumab biosimilar in Japan

Biosimilars/News | Posted 30/04/2021 post-comment0 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).

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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].

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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

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Source: Korea Biomed, LG Chem

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