Organon Acquires U.S. Rights to TOFIDENCE from Biogen
Organon (NYSE: OGN) announced today that it has acquired regulatory and commercial rights in the...
Biosimilars
Henlius and Organon’s HLX11 Biosimilar Clears EMA Validation Hurdle
Shanghai Henlius Biotech, Inc. (HKG: 2696) and Organon (NYSE: OGN) announced that the European Medicines...
Huadong Medicine’s Semaglutide Injection Accepted for Review by China’s NMPA
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that the National Medical Products Administration (NMPA)...
Bio-Thera Solutions Inks Licensing Deal with Dr. Reddy’s for Biosimilar Commercialization
Guangzhou-based Bio-Thera Solutions (SHA: 688177) has entered into a licensing agreement with India-headquartered Dr. Reddy’s...
Tonghua Dongbao Initiates Phase III Trial for Insulin Degludec, Liraglutide Combo in Type 2 Diabetes
China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) has initiated a Phase III clinical study for its...
Bio-Thera Solutions Inks Licensing Deal with World Medicine for BAT2206
China-based Bio-Thera Solutions (SHA: 688177) has entered into a licensing agreement with World Medicine, granting...
Sinocelltech’s Finotonlimab Gets NMPA Approval for Liver Cancer Treatment
China-based Sinocelltech Group Ltd (SHA: 688520) announced that it has received another indication approval from...
Sandoz Launches Pyzchiva Biosimilar of J&J’s Stelara in US
Switzerland-based Sandoz (SWX: SDZ) announced the launch of Pyzchiva, a biosimilar version of Johnson &...
Huadong Medicine’s Biosimilar Tresiba Accepted by NMPA for Review
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market filing for a biosimilar...
Henlius Biotech’s Avastin Biosimilar Hanbeitai Approved in Bolivia
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that its biosimilar of Roche’s Avastin (bevacizumab), Hanbeitai,...
Samsung Bioepis’ Ospomyv and Xbryk Gain FDA Approval for RANKL Inhibitor Biosimilars
South Korea-based Samsung Bioepis Co., Ltd. announced that it has received marketing approval from the...
Huadong Medicine’s Biosimilar SaiYueXin Seeks NMPA Approval for Crohn’s Disease
Huadong Medicine Co., Ltd (SHE: 000963) announced that another indication approval filing for its SaiYueXin,...
Kexing Biopharm and Bio-Thera Solutions Form Alliance for Global Expansion
China-based Kexing Biopharm (SHA: 688136) and Bio-Thera Solutions Ltd (SHA: 688177) have formed a strategic...
CSPC Pharmaceutical’s Omalizumab Biosimilar Wins NMPA Approval for Allergic Asthma
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has received an additional indication approval from the...
Bio-Thera Solutions Licenses BAT2506 to Intas Pharmaceuticals for US Market
China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that it has entered into a licensing agreement...
Sichuan Kelun-Biotech’s Datailai Gains NMPA Approval for Colorectal Cancer Treatment
China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that it has received marketing approval...
Henlius Biotech Licenses HLX15 to Dr. Reddy’s for US and European Markets
China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced a licensing deal with India-headquartered Dr. Reddy’s...
United Laboratories’ Biosimilar Semaglutide Accepted for Review by China’s NMPA
Hong Kong-listed United Laboratories International Holdings Ltd (HKG: 3933) has announced that its market filing...
Henlius and Abbott Sign License Agreement for Biosimilars and Biologic Drug
China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced a strategic license agreement with Abbott...
Samsung Bioepis and Teva Partner on Biosimilar EPYLLI for US Market
South Korea’s Samsung Bioepis and Israel-based Teva Pharmaceutical (NYSE: TEVA) have entered into a license,...