FDA Issues Draft Guidance to Accelerate Biosimilar Development and Cut Costs
The U.S. Food and Drug Administration (FDA) released a draft guidance titled “Scientific Considerations in...
Biosimilars
Henlius Organon Secure EU Marketing Approval for BILDYOS and BILPREVDA Denosumab Biosimilars
Shanghai Henlius Biotech, Inc. (HKG: 2696) and Organon (NYSE: OGN) announced that the European Commission...
Bio-Thera Partners with Jamjoom Pharma to Launch BAT2306 Biosimilar in MENA
Guangzhou-based Bio-Thera Solutions Ltd. (SHA: 688177) announced on September 15, 2025, that it has entered...
Taiji Group Secures NMPA Approval to Begin Clinical Trials of Semaglutide Biosimilar
China‑based Chongqing Taiji Industry (Group) Co., Ltd. (Taiji Group, SHA: 600129) announced that its semaglutide...
Shanghai Henlius Biotech Secures FDA IND Approval for HLX17, a Pembrolizumab Biosimilar
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the U.S. Food and Drug Administration (FDA)...
Fosun Secures FDA Approval for Two Denosumab Biosimilar Formulations
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196, SHA: 600196) announced that the Biologics License...
Mabwell Secures First Overseas Approval for Denosumab Biosimilars in Pakistan
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that the Drug Regulatory Authority of Pakistan...
Bio-Thera Adjusts BAT3306 Clinical Study to Meet Regulatory Standards
On August 21, 2025, China-based Bio-Thera Solutions, Ltd. (SHA: 688177) announced a strategic adjustment to...
Henlius Biotech’s HLX04-O Accepted by NMPA for Wet AMD Treatment
Shanghai Henlius Biotech Inc. (HKG: 2696) announced on August 13, 2025, that the marketing authorization...
Shandong Boan’s Boyouping Receives NMPA Approval for Type 2 Diabetes Treatment
Shandong Boan Biotechnology Co., Ltd (HKG: 6955) announced on August 8, 2025, that its self-developed...
Mabwell Signs Licensing Agreement with Unilab for Denosumab Biosimilars in the Philippines
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced a licensing agreement with Unilab, Inc.,...
Shanghai Henlius Biotech Earns GMP Certification for Prolia/Xgeva Biosimilar HLX14 and Perjeta Biosimilar HLX11
China’s Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that it has received Good Manufacturing Practice...
Chengdu Kanghong Receives NMPA Approval for Clinical Trials of KH813 in Metastatic nsq-NSCLC
China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) announced that it has received clinical...
Huadong Medicine Files for NMPA Approval of Ranibizumab Biosimilar
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market approval filing for a...
Betta Pharmaceuticals Partners with BioRay for Herceptin Biosimilar Anruize
China-based Betta Pharmaceuticals (SHE: 300558) announced a strategic partnership with fellow domestic firm BioRay Biopharmaceutical....
Bio-Thera Solutions Terminates BAT3306 Trial Amid Biosimilar Policy Shifts
Guangzhou-based biotech Bio-Thera Solutions (SHA: 688177) announced the termination of a multi-center, randomized, double-blinded Phase...
Bio-Thera Solutions’ BAT2206 Biosimilar of Stelara Gains FDA Approval
Guangzhou-based Bio-Thera Solutions Ltd. (SHA: 688177) announced that it has received Biologic License Application (BLA)...
Shanghai Henlius Biotech Doses First Patient in Phase I/III Study of HLX13 for Hepatocellular Carcinoma
Shanghai Henlius Biotech Inc. (HKG: 2696) announced the completion of first patient dosing in a...
Nanjing King-Friend Bio’s Biosimilar Victoza Approved by FDA
China-based Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (SHA: 603707) announced that its Abbreviated New Drug...
Organon Acquires U.S. Rights to TOFIDENCE from Biogen
Organon (NYSE: OGN) announced today that it has acquired regulatory and commercial rights in the...