Japanese-developed Aranesp biosimilar shows equivalence in Phase III study

Positive results of the Phase III study for JR-131, a proposed biosimilar to darbepoetin alfa, a long-acting erythropoiesis-stimulating agent for the treatment of renal anemia, have been announced by Japanese drugmakers Kissei Pharmaceutical (TYO: 4547) and JCR Pharmaceuticals (TYO: 4552).

In 2013, the companies announced the collaboration to develop a biosimilar of darbepoetin alfa, the active ingredient of biotech giant Amgen’s (Nasdaq: AMNG) Aranesp, which in the third-quarter of 2017 generated sales of $516 million, down from $531 million.

In the Phase III study initiated in August 2016, JR-131 demonstrated equivalence in efficacy and safety compared with darbepoetin. Accordingly, in a primary endpoint of efficacy, the equivalence was verified for variations in hemoglobin concentration and the similarity with regard to the safety profile was confirmed.

Kissei and JCR concluded a collaborative R&D agreement for JR-131 in September 2013, and have been advancing the development with the aim to apply for marketing approval in 2018. JR-131 which offers economic efficiency, can become a new treatment option in the renal diseases areas, they said.

Both companies are aiming to contribute to healthcare through the development of JR-131, by leveraging JCR's strong know-how and expertise in biopharmaceutical manufacturing that meets the global quality standards, and Kissei's outstanding performance in the renal diseases including dialysis areas and sales results of the first biosimilar in Japan, "Epoetin alfa BS Injection [JCR]."