LG Life Sciences is currently carrying out a phase I clinical study of its biosimilar (LBAL) in South Korea, according to ClinicalTrials.gov. The trial is being carried out to study the pharmacokinetics, safety and tolerability of LBAL compared to the originator biological, AbbVie’s Humira (adalimumab) and is expected to be completed in March 2015.

AbbVie’s blockbuster autoimmune disease treatment Humira is a tumour necrosis factor (TNF) inhibitor that is approved to treat rheumatoid, juvenile rheumatoid and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis, and ulcerative colitis.

LG Life Sciences will receive technology and milestone payments to accelerate the biosimilar to market in both Korea and Japan. Mochida will have exclusive rights for the development and sale of the adalimumab biosimilar in Japan. LG Life Sciences will supply the biosimilar to Mochida.

LG Life Sciences is also developing an etanercept biosimilar (LBEC0101), for which it has already completed a phase I trial [1]. While Mochida has biosimilar agreements in place with Japan-based Fuji Pharma and Hungary-based Gedeon Richter. In fact, Mochida and partner Fuji Pharma already filed respective applications for the first biosimilar granulocyte colony-stimulating factor (G-CSF) in Japan in November 2011 [2].

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Japanese firms developing biosimilars

References
1.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars of etanercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 31]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-etanercept 
2.  GaBI Online - Generics and Biosimilars Initiative. First biosimilar G-CSF in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 31]. Available from: www.gabionline.net/Biosimilars/News/First-biosimilar-G-CSF-in-Japan 

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