Darbepoetin Alfa BS (darbepoetin alfa biosimilar) / JCR Pharma, Kissei - LARVOL DELTA

Physicochemical and biological evaluation of JR-131 as a biosimilar to a long-acting erythropoiesis-stimulating agent darbepoetin alfa. (PubMed, PLoS One) - "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."

Journal • Gene Therapies • Hematological Disorders

JCR pulls Japanese Temcell filing; gains approval for darbepoetin alfa (The Pharma Letter) - "JCR...gains approval for Darbepoetin Alfa..."

Japanese regulatory

JCR's proposed darbepoetin alfa biosimilar performs in phase 3 program (Center for Biosimilars) - P3, N=334; "The investigators report that the 95% CI of the difference in the change in hemoglobin level between the groups was −0.19 g/dL to −0.20 g/dL, which fell within the prespecified the equivalence margin of −0.5 g/dL to 0.5 g/dL." P3, N=159; "No adverse drug reactions were reported, and no antidrug antibodies were detected. Hemoglobin levels were maintained in the range of 10.0 to 12.0 g/dL throughout the study."

P3 data

JR-131, a biosimilar of darbepoetin alfa, for the treatment of hemodialysis patients with renal anemia: a randomized, double-blinded, parallel-group phase 3 study. (PubMed, Ther Apher Dial) - "No notable 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."

Clinical • Journal • P3 data

Long-term (52 weeks) safety and efficacy of JR-131, a biosimilar of darbepoetin alfa, in Japanese patients with renal anemia undergoing hemodialysis; Phase 3 prospective study. (PubMed, Ther Apher Dial) - "The hemoglobin levels were maintained in the range of 10.0-12.0 g/dL throughout the study. JR-131 probed to be a useful and lower cost alternative to darbepoetin alfa in the management of renal anemia in patients undergoing hemodialysis."

Clinical • Journal • P3 data