Analysis of results from the phase I trial of CKD Pharma’s darbepoetin alfa biosimilar (CKD-11101) compared with Nesp (darbepoetin alfa) showed a comparable pharmacokinetic, pharmacodynamic and tolerability profile to that of Nesp and there were no issues of adverse events after administration of CKD-11101.

Nesp, which is a synthetic form of erythropoietin, is marketed by Kyowa Hakko Kirin in South Korea. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.

According to ClinicalTrials.gov, CKD Pharma’s trial was a double-blind, randomized, active-controlled, single-dosing, crossover study. The main objective of the study was to investigate the pharmacokinetics of CKD-11101 and Nesp after intravenous administration in healthy male volunteers

The trial, which was carried out at the Seoul National University Hospital, enrolled an unspecified number of healthy male volunteers aged 20−55 years. Subjects were randomized to receive a solution of CKD-11101 and Nesp intravenously (crossover) at a dose of 60 mg. Measurement of pharmacokinetic and safety parameters was carried out before and after taking each medication. The primary completion date of this trial was January 2013.

Two brand-name versions of darbepoetin alfa, Amgen’s Aranesp and Kyowa Hakko Kirin’s Nesp are currently marketed; Aranesp and Nesp had 2013 sales of US$2.4 billion.

The patents on Aranesp are set to expire in Europe in 2016, in the US in 2024 [1]. For Nesp (Amgen and Kyowa Hakko Kirin) patents are set to expire in Japan in 2019.

CKD Pharm is planning to start a phase III clinical study for CKD-11101 at the end of 2014 and expects to submit its application for Korean approval in 2018.

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Reference
1.   GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 9]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020 

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