Etanercept biosimilar submitted for approval in Japan

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Etanercept biosimilar submitted for approval in Japan

Biosimilares/Novedades | Posted 17/02/2017 0 Post your comment

Japan-based Mochida Pharmaceutical (Mochida) has submitted an application for marketing approval for an etanercept biosimilar (LBEC0101) to the Japanese medicines regulatory agency – the Pharmaceuticals and Medical Devices Agency (PMDA).

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

Mochida’s product is a proposed biosimilar of Amgen/Pfizer’s Enbrel (etanercept), which had worldwide sales of US$8.7 billion in 2015. The patents on Enbrel will expire in the US in November 2028, after Amgen was granted a new patent; and expired in Europe in August 2015 [1, 2].

Mochida has in-licensed LBEC0101 from LG Life Sciences (which has recently merged with LG Chem) for the Japanese market. According to ClinicalTrials.gov, LG Life Sciences has two ongoing phase III studies for LBEC0101 in rheumatoid arthritis patients.

Mochida has also in-licensed an adalimumab biosimilar (LBAL) from LG Life Sciences and a teriparatide biosimilar (RGB-10) from Gideon Richter.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 17]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
2. GaBI Online - Generics and Biosimilars Initiative. New Amgen Enbrel patent could block biosimilars until 2028 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 17]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028

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Source: Mochida