Positive Phase 3 Results for Japanese Aranesp Biosimilar

Japanese drug makers Kissei Pharmaceutical Company and JCR Pharmaceuticals have announced positive results of a phase 3 study for JR-131, a proposed biosimilar to darbepoetin alfa (Aranesp).

Darbepoetin alfa is a long-acting erythropoiesis-stimulating agent for the treatment of renal anemia in people with chronic kidney failure. The therapy is also used to treat anemia caused by chemotherapy in people with certain types of cancer.

The phase 3 study began in August 2016. In the study’s primary efficacy endpoint, JR-131 demonstrated equivalence for variations in hemoglobin concentration and similarity with regard to the 2 products’ safety profiles was confirmed.

Amgen, the maker of the originator product, received FDA approval for Aranesp in 2001, and in 2016, the company reported $526 million in sales of the drug.

Certain drug manufacturers have already launched biosimilars of darbepoetin alfa in less highly regulated territories; companies such as Hetero Drugs, Dr. Reddy’s Laboratories, and Torrent Pharmaceuticals have all launched darbepoetin alfa biosimilars in India, some as early as 2010.

Kissei and JCR entered into a collaborative research and development agreement for JR-131 in September 2013, and aim to apply for marketing approval later in 2018.

The drug makers’ efforts are part over an overall uptick in the Japanese market, which some analysts predict will continue throughout 2018. According to a recent report from CPhI Japan, demographic pressures are increasing healthcare costs, making cost-saving options an appealing investment. As a result, the development of biosimilars and generics are expected to experience rapid growth in 2018.

“The Japanese pharma industry has recently made attempts to attract more global business and the report findings demonstrate that there are more opportunities than ever for new players to penetrate the market, particularly in generics and biosimilars,” said brand manager of CPhI Japan, Laura Murina. “This year, CPhI Japan will continue to provide a platform for the global pharma community to convene, fostering even greater links between the domestic and international markets, and maintaining Japan’s position as a tier-one pharma business destination.”