Chong Kun Dang announced it has signed a commercialisation agreement with Menagen for Nesbell® (biosimilar darbepoetin alfa). Under the agreement, Chong Kun Dang will receive a down payment and milestone payments in exchange for exclusive commercialisation rights in Oman, Saudi Arabia, UAE, Kuwait Qatar and Bahrain.

Dong-A ST announces sales approval for biosimilar darbepoetin from Japan’s Ministry of Health, Labour and Welfare. 

Lotus Pharma announces it has signed a commercialisation agreement with Chong Kun Dang for Nesbell® (biosimilar darbepoetin-alpha). Under the agreement, Chong Kun Dang will supply Lotus with Nesbell® for sale in Taiwan, Vietnam and Thailand pending the success of clinical trials in those countries.

JCR announces results of Ph III trials of biosimilar darbepoetin candidate JR131 in patients with renal anemia. 159 patients enrolled in the 52 week study, with JCR reporting no adverse drug reactions, and that patient hemoglobin levels remained within the required 10.0 to 12.0 g/dL range throughout the study.

Chong Kun Dang announces approval for biosimilar darbepoetin from the Ministry of Food and Drug Safety of South Korea. This is the first biosimilar darbepoetin to be approved in a highly regulated country.

Kissei announces positive Ph III trials for JR131, biosimilar darbepoetin, with a view toward regulatory filing in 2018.