Intas Pharmaceuticals Receives FDA Approval for Biosimilar Stelara, Expanding Treatment Options for Autoimmune Diseases
Intas Pharmaceuticals Ltd, an Indian pharmaceutical company and partner of China’s Shanghai Henlius Biotech Inc....
Biosimilars
CSPC Pharmaceutical Secures NMPA Approval for Omalizumab Biosimilar
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received marketing approval...
Bio-Thera Solutions Ltd Strikes Licensing Deal with Gedeon Richter for BAT1706 Biosimilar
Guangzhou-based Bio-Thera Solutions Ltd has announced a licensing agreement with Hungary’s Gedeon Richter Plc for...
China’s CDE Releases Draft Guidelines for Biosimilar Drug Labeling
On September 29, 2024, the Center for Drug Evaluation (CDE) of China’s National Medical Products...
China’s CDE Issues Draft Guidelines for Biosimilar Pharmaceutical Similarity Research
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has released...
Henlius Biotech’s HLX17 Biosimilar to MSD’s Keytruda Wins NMPA Clinical Trial Approval
SHANGHAI—Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clinical trial approval...
Biocon Biologics Resolves Patent Dispute with J&J, Secures Market Entry for Biosimilar Stelara
Biocon Biologics Ltd, the biosimilars division of Indian pharmaceutical company Biocon Ltd (BOM: 532523, NSE:...
Hybio Pharmaceutical Inks Licensing Deal with Mullan Pharmaceutical for Liraglutide Biosimilar
BEIJING—Hybio Pharmaceutical Co., Ltd (SHE: 300199), a Chinese biopharmaceutical company, has entered into a licensing...
Bio-Thera Solutions’ BAT2406 Biosimilar Gets Green Light for Clinical Trials in China
GUANGZHOU—Bio-Thera Solutions (SHA: 688177), a leading biopharmaceutical company based in Guangzhou, has received approval from...
Henlius Biotech’s Biosimilar Herceptin Approved by Health Canada for Breast and Gastric Cancer Treatments
Shanghai Henlius Biotech Inc., a leading biopharmaceutical company based in China and listed on the...
Qilu Pharmaceutical’s Biosimilar Ranibizumab Receives NMPA Approval, Marking a First in China
Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its biosimilar version of Novartis’s blockbuster...
Bio-Thera Solutions Expands Reach with New Licensing Deal for Biosimilar BAT2306
Guangzhou-based Bio-Thera Solutions (SHA: 688177) has entered into a new licensing agreement with Russian firm...
Sihuan Pharmaceutical Secures NMPA Approval for First Biosimilars of Novo Nordisk’s Diabetes Drugs
Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has secured separate marketing approvals from China’s National...
Mabwell Bioscience Partners with Cristália for Biosimilar Denosumab in Brazil
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has entered...
Gan & Lee Pharmaceuticals Gets FDA Green Light for Phase I Clinical Trial of Insulin Aspart Biosimilar
Gan & Lee Pharmaceuticals (SHA: 603087), a leading pharmaceutical company based in China, has received...
Bio-Thera Solutions’ Bevacizumab Biosimilar Avzivi Receives European Commission Approval
Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that its biosimilar version of Roche’s Avastin, Avzivi...
Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA
Bio-Thera Solutions Ltd, a biopharmaceutical company based in Guangzhou, has announced the submission of Biologic...
Ocumension Therapeutics and Shandong Boan Biotechnology File for Market Approval of Biosimilar Aflibercept in China
Ocumension Therapeutics (HKG: 1477) and Shandong Boan Biotechnology Co., Ltd (HKG: 6955) have jointly announced...
U.S. Senate Passes Affordable Prescriptions for Patients Act to Limit Patent Thicketing
In a significant move to curb drug prices, the U.S. Senate unanimously passed the Affordable...
MabPharm’s Biosimilar Infliximab CMAB807 Receives Market Approval in Peru
MabPharm Ltd (HKG: 2181), a biosimilar specialist in monoclonal antibody (mAb) based in Taizhou, has...