Daiichi Sankyo ends deal with Coherus for etanercept biosimilar in Japan

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Daiichi Sankyo announced on 5 July 2017 that it was ending its co-development in Japan with Coherus BioSciences (Coherus) of a biosimilar to Amgen’s arthritis drug Enbrel (etanercept).

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The announcement signals the end to a five-year partnership between the two companies. Japan-based Daiichi Sankyo and US-based biosimilars specialist Coherus made an exclusive agreement to develop and commercialize biosimilars of etanercept and rituximab in certain Asian countries including Japan back in May 2012 [1].

The biosimilar (CHS‑0214) met its primary endpoint, evaluating the disease activity of rheumatoid arthritis and, according to Coherus ‘demonstrating the equivalence of CHS‑0214 to Enbrel’.

However, Daiichi Sankyo says that ‘due to the fact that a commercial manufacturing process to enable the feasible supply of CHS‑0214 in Japan cannot be established at this time’, the company ‘has decided to discontinue the development of CHS‑0214 in Japan’.

The companies failed to mention anything about the rituximab part of the deal.

Rival Japan-based biosimilars maker Mochida Pharmaceutical (Mochida) submitted an application for marketing approval for its etanercept biosimilar (LBEC0101) to the Japanese medicines regulatory agency – the Pharmaceuticals and Medical Devices Agency in February 2017 [2].

Daiichi Sankyo does have another deal for biosimilars in Japan with US-based biologicals specialist Amgen. The two companies made an exclusive agreement to commercialize nine biosimilars in Japan in July 2016 [3].

The end of this etanercept deal, however, comes as a second setback in the last months for Coherus. The US Food and Drug Administration rejected the company’s application for its candidate pegfilgrastim biosimilar, CHS‑1701 in June 2017 [4].

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1. GaBI Online - Generics and Biosimilars Initiative. Daiichi Sankyo and Coherus Biosciences make biosimilars deal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 7]. Available from: www.gabionline.net/Biosimilars/News/Daiichi-Sankyo-and-Coherus-BioSciences-make-biosimilars-deal

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Source: Daiichi Sankyo

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