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

AbstractThe aim of this study was to compare the efficacy and safety of intravenous JR‐131, a darbepoetin alfa biosimilar, to darbepoetin alfa in hemodialysis patients with renal anemia. In this 24‐week, multicenter, randomized, double‐blinded, parallel‐group phase 3 study, 334 hemodialysis patients with renal anemia who had been receiving darbepoetin alfa were randomized to either JR‐131 or darbepoetin alfa group. The initial dose was set based on the darbepoetin alfa dose during the observation period. The primary endpoint was change in hemoglobin level from baseline to end of treatment. The 95% confidence interval of the difference in the change in hemoglobin level between the groups was −0.19 to −0.20 g/dL, within the equivalent margin of −0.5 to 0.5 g/dL. No notable treatment‐emergent adverse events were observed in either group. JR‐131 was therapeutically equivalent to darbepoetin alfa, and the safety profile of JR‐131 was similar to that of darbepoetin alfa.

01 Apr 2020·Therapeutic Apheresis and Dialysis

Long‐Term Safety and Efficacy of JR‐131, a Biosimilar of Darbepoetin Alfa, in Japanese Patients With Renal Anemia Undergoing Hemodialysis: Phase 3 Prospective Study

Article

Author: Masakane, Ikuto ; Nakamoto, Hidetomo ; Nishi, Shinichi ; Yamada, Masayuki ; Tsuruya, Kazuhiko

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 ; Kakimoto, Shinji ; Minami, Kohtaro ; Ito, Yae ; Hirato, Tohru ; Kotani, Ayaka ; Fukui, Tsuyoshi ; Tani, Junya ; Yamamoto, Ryuji ; 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.)

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	B03XA02	DB00012

R&D Status

Approved

10 top approved records.

Login

to view more data

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

Developing

10 top R&D records.

Login

to view more data

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

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02912533 (Pubmed) Manual	Phase 3	Anemia of renal disease	159	JR-131	(ptxfweeuhi) = no notable AE szfkdoklye (vvvpqhxlpx )	Positive	01 Apr 2020
NCT02912494 (Pubmed \| Ther Apher Dial) Manual	Phase 3	Anemia	334	JR-131	(axouwbilss) = zabtxamnyi egfbddwegz (cgbzwpmxsv, 0.73 ) View more	Similar	01 Apr 2020
NCT02912494 (Pubmed \| Ther Apher Dial) Manual	Phase 3	Anemia	334	darbepoetin alfa	(axouwbilss) = pgjigwwinw egfbddwegz (cgbzwpmxsv, 0.77) View more	Similar	01 Apr 2020