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Kissei/JCR’s darbepoetin alfa biosimilar shows equivalent safety and efficacy Posted 02/03/2018

Japan-based collaborators Kissei Pharmaceutical (Kissei) and JCR Pharmaceuticals (JCR) announced on 17 January 2018 positive results for the phase III study of their candidate darbepoetin alfa biosimilar, JR‑131.

Darbepoetin alfa is a synthetic form of erythropoietin. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.

The phase III trial investigated the equivalence of JR‑131 to darbepoetin alfa and evaluated the safety of JR‑131 in renal anaemia patients with chronic kidney disease (CKD). The trial was started back in August 2016 and was planned to be completed in February 2018.

The phase III study showed that ‘JR‑131 demonstrated equivalence in efficacy and safety compared with darbepoetin’, according to the companies. In addition, for the primary efficacy endpoint, the companies stated that ‘equivalence was verified for variations in haemoglobin concentration and the similarity with regard to the safety profile was confirmed’.

Kissei and JCR concluded a collaborative research and development agreement for JR‑131 in September 2013. They aim to apply for marketing approval for the biosimilar in 2018.

Editor’s comment
It should be noted that data of the study presented in this article were published as a press release. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

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Source: clinicaltrials.gov, JRC, Kissei

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