JCR's Proposed Darbepoetin Alfa Biosimilar Performs in Phase 3 Program

JCR Pharmaceuticals, together with partner Kissei Pharmaceutical, is currently developing a darbepoetin alfa biosimilar, JR-131, referencing Aranesp. Darbepoetin alfa is used to treat anemia caused by chronic kidney disease or by chemotherapy.

Recently, the drug maker revealed results of its phase 3 program for the proposed biosimilar; in a 24-week, multicenter, randomized, double-blind, parallel-group phase 3 study, 334 patients with renal anemia were enrolled.¹

All patients had been receiving the reference drug to treat their anemia, and they were randomized to either continue to receive the reference or to receive the proposed biosimilar. The primary end point was change in hemoglobin level from baseline to the end of treatment.

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.

No notable adverse events occurred in either treatment arm.

Next, in a long-term safety and efficacy analysis of the biosimilar, 159 patients with renal anemia who had been receiving the reference drug or other recombinant human erythropoietins were given the biosimilar intravenously for 52 weeks.²

Patients who had been taking the reference product continued to receive the same dose of the biosimilar, and those who had taken recombinant human erythropoietin previously received a dose of the biosimilar based on a conversion ratio.

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.

These findings, write the authors, show the therapeutic equivalence of the biosimilar and the reference, and they support the use of the biosimilar as a lower-cost alternative to the reference product in managing renal anemia.

JCR, in partnership with Amicus Therapeutics and GlaxoSmithKline, has successfully launched 1 previous biosimilar: an agalsidase beta biosimilar for the treatment of Fabry disease, a lysosomal storage disorder.

References

1. Nishi S, Yamada M, Tsuruya K, Masakane I, Nakamoto H. 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 [published online July 19, 2019]. Ther Apher Dial. doi: 10.1111/1744‐9987.13422.

2. Nishi S, Yamada M, Tsuruya K, Masakane I, Nakamoto H. 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 [published online July 14, 2019]. Ther Apher Dial. doi: 10.1111/1744‐9987.13420.