Delving into the Latest Updates on Darbepoetin alfa biosimilar(JCR Pharmaceuticals Co., Ltd.) with Synapse

AbstractThe objective of this study was to evaluate the safety and efficacy of JR‐131, a biosimilar of darbepoetin alfa, for long‐term treatment of renal anemia patients undergoing hemodialysis. In this multicenter, single‐arm, phase 3 study, 159 patients with renal anemia who had been receiving darbepoetin alfa or recombinant human erythropoietins were treated with intravenous JR‐131 for 52 weeks. In patients receiving darbepoetin alfa, JR‐131 was administered at the same dose, while in patients receiving recombinant human erythropoietin the dose was determined based on the 1:200 conversion ratio following the Japanese darbepoetin alfa package insert. No notable adverse drug reactions were reported, and no anti‐JR‐131 antibodies were detected. The hemoglobin levels were maintained in the range of 10.0–12.0 g/dL throughout the study. JR‐131 proved to be a useful and lower‐cost alternative to darbepoetin alfa in the management of renal anemia in patients undergoing hemodialysis.

PLOS ONEQ3 · CROSS-FIELD

Physicochemical and biological evaluation of JR-131 as a biosimilar to a long-acting erythropoiesis-stimulating agent darbepoetin alfa

Q3 · CROSS-FIELD

ArticleOA

Author: Yamakami, Makoto ; Sugimura, Atsushi ; Tatemichi, Satoshi ; Mihara, Kazutoshi ; Hatano, Yukichi ; Minami, Kohtaro ; Kakimoto, Shinji ; Ito, Yae ; Hirato, Tohru ; Kotani, Ayaka ; Fukui, Tsuyoshi ; Yamamoto, Ryuji ; Tani, Junya ; Tanaka, Noboru ; Takahashi, Kenichi

Renal anemia is predominantly caused by a relative deficiency in erythropoietin (EPO). Conventional treatment for renal anemia includes the use of recombinant human EPO (rhEPO) or a long-acting erythropoiesis-activating agent named darbepoetin alfa, which is a modified rhEPO with a carbohydrate chain structure that differs from native hEPO. We have developed a biosimilar to darbepoetin alfa designated JR-131. Here, we comprehensively compare the physicochemical and biological characteristics of JR-131 to darbepoetin alfa. JR-131 demonstrated similar protein structure to the originator, darbepoetin alfa, by peptide mapping and circular dichroism spectroscopy. Additionally, mass spectroscopic analyses and capillary zone electrophoresis revealed similar glycosylation patterns between the two products. Human bone marrow-derived erythroblasts differentiated and proliferated to form colonies with JR-131 to a similar degree as darbepoetin alfa. Finally, JR-131 stimulated erythropoiesis and improved anemia in rats similarly to darbepoetin alfa. Our data show the similarity in physicochemical and biological properties of JR-131 to those of darbepoetin alfa, and JR-131 therefore represents a biosimilar for use in the treatment of renal anemia.

100 Deals associated with Darbepoetin alfa biosimilar(JCR Pharmaceuticals Co., Ltd.)

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Indication	Country/Location	Organization	Date
Anemia of renal disease	Japan	JCR Pharmaceuticals Co., Ltd.	20 Sep 2019

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Indication	Highest Phase	Country/Location	Organization	Date
Anemia of renal disease	Phase 1	Japan	Kissei Pharmaceutical Co., Ltd.	01 Sep 2016
Chronic Kidney Diseases	Phase 1	Japan	JCR Pharmaceuticals Co., Ltd.	01 Sep 2016
Chronic Kidney Diseases	Phase 1	Japan	Kissei Pharmaceutical Co., Ltd.	01 Sep 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02912494 (Pubmed \| Ther Apher Dial) Manual	Phase 3	Anemia	334	JR-131	(ejayxxpaim) = olizunesns pqzhvmjawp (vkznlczmnd, 0.73 ) View more	Similar	01 Apr 2020
NCT02912494 (Pubmed \| Ther Apher Dial) Manual	Phase 3	Anemia	334	darbepoetin alfa	(ejayxxpaim) = qcyyrmeegf pqzhvmjawp (vkznlczmnd, 0.77) View more	Similar	01 Apr 2020
NCT02912533 (Pubmed) Manual	Phase 3	Anemia of renal disease	159	JR-131	(ehagwpylon) = no notable AE jfkvvdsdot (myjesjhnok )	Positive	01 Apr 2020

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