Fuji Pharma gains rights to darbepoetin alfa biosimilar in Japan

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Japan-based Fuji Pharma announced on 5 January 2016 that it had signed a license agreement with Chong Kun Dang Pharmaceutical (CKD Pharma). Under the agreement, Fuji Pharma has the exclusive rights in Japan for the development, manufacture, distribution and sale of CKD Pharma’s darbepoetin alfa biosimilar (CKD‑11101).

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Darbepoetin alfa is a synthetic form of erythropoietin. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia. The drug is effective for improving renal anaemia seen in patients with non-dialysis chronic kidney disease and in haemodialysis patients and is widely used in Japan.

A darbepoetin alfa biosimilar from Kyowa Hakko Kirin was approved in Japan in 2013 [1].

CKD Pharma is still developing its darbepoetin alfa biosimilar. The company has already completed a phase I pharmacokinetics study of CKD-11101 compared to the originator Nesp (darbepoetin alfa) after SC and IV administration in healthy male volunteers. The results of the study showed that CKD-11101 had a comparable pharmacokinetic, pharmacodynamic and tolerability profile to that of Nesp and there were no issues of adverse events after administration of CKD-11101 [2].

This will be Fuji Pharma’s second biosimilar. The company’s Filgrastim BS injection, a recombinant human granulocyte colony-stimulating factor (G-CSF), was approved in November 2012. Filgrastim BS was developed with partner Mochida Pharmaceuticals and was the first biosimilar G-CSF in Japan [3].

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1.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Japan  
2.  GaBI Online - Generics and Biosimilars Initiative. Phase I study shows darbepoetin alfa biosimilar to be well tolerated [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 12]. Available from: www.gabionline.net/Biosimilars/Research/Phase-I-study-shows-darbepoetin-alfa-biosimilar-to-be-well-tolerated  
3.  GaBI Online - Generics and Biosimilars Initiative. Approval of first biosimilar G-CSF in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 12]. Available from: www.gabionline.net/Biosimilars/News/Approval-of-first-biosimilar-G-CSF-in-Japan  

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Source: Fuji Pharma

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