Biosimilar Market Updates: Russia, Japan, Australia

On September 17, Russian drug manufacturer Generium announced that its dornase alfa biosimilar, Tigerase®, has been approved and launched in Russia. Tigerase® references Genentech’s Pulmozyme® and is the first dornase alfa biosimilar to be approved in any market worldwide. Dornase alfa is used in combination with other therapies to improve pulmonary function in patients with cystic fibrosis, and is one of the few biologic drugs that is approved for administration by inhalation.

On September 24, the South Korean drug manufacturer Chong Kun Dang (CKD) announced that it received Japanese manufacturing and marketing approval for CKD-11101, a biosimilar of ARANESP (darbepoetin alfa) indicated for the treatment of anemia in patients with chronic kidney disease and patients undergoing chemotherapy. One day earlier, it was reported that Korean company Dong-A ST announced that its darbepoetin alfa biosimilar, DA-3880, also received marketing approval in Japan. Dong-A ST licensed DA-3880 to its Japanese partner Sanwa Kagaku Kenkyusho (SKK), which will market the drug in Japan.

On September 30, Juno Pharmaceuticals announced its partnership with Celltrion Healthcare Australia to market the biosimilar cancer therapies Herzuma® (trastuzumab) and Truxima® (rituximab). According to the press release, Juno will provide sales promotion and hospital contracting services for the biosimilars and Celltrion Healthcare Australia will distribute the products to the Australian market.