Eye on Pharma: Japan to Review Darbepoetin Alfa Biosimilar

Korean media are reporting that Dong-A ST, a biosimilar developer based in the Republic of Korea, has, together with Sanwa Kagaku Kenkyusho (SKK), filed for Japanese regulatory approval of DA-3880, a darbepoetin alfa biosimilar referencing Aranesp.

The reference product, made by Amgen, is an erythropoiesis-stimulating agent that is indicated to treat anemia that arises from chronic kidney disease or from myelosuppressive chemotherapy.

Read more about darbepoetin alfa.

The partnership expects to receive a regulatory decision within 12 months of having filed its application, and if the biosimilar is approved, SKK will handle distribution of the product in Japan. The companies hope to gain a share of a Japanese market for darbepoetin alfa that is worth the equivalent of $439 million.

Dong-A ST and SKK are not the only Asian biosimilar developers targeting darbepoetin alfa; Korean company Chong Kun Dang Pharamceutical has completed a phase 3 clinical study to evaluate its own biosimilar candidate, CDK-11101, versus the reference Aranesp in 248 patients with chronic renal failure who were not receiving hemodialysis or peritoneal dialysis.

Additionally, Japanese companies Kissei Pharmaceutical and JCR Pharmaceuticals have announced positive topline results from their phase 3 study of JR-131. The study met its primary endpoint of demonstrating equivalence for variations in hemoglobin concentration, and similarity with respect to safety was also confirmed. The companies have announced a goal of applying for a marketing authorization for the drug in 2018.

Meanwhile, the originator product is repositioning itself in the marketplace; in August 2018, Japanese drug maker Kyowa Hakko Kirin announced that its subsidiary, Kyowa Kirin Frontier, had been awarded a manufacturing and marketing approval for an “authorized version” of the reference darbepoetin alfa in an injection syringe presentation.

Kirin holdings originally developed the branded originator, Aranesp, together with Amgen under a 1984 agreement, and in 2017, the Kirin-Amgen joint venture became a wholly-owned subsidiary of Amgen. The new Japanese licensure allows Kyowa Hakko Kirin to market the injection presentation of the reference product in the Japanese marketplace.

At the time of the announcement, the drug maker indicated that it was working to establish a stable supply of the product in its syringe device for use in the Japanese health system.