Bio‑Thera Expands Intas Partnership to India – BAT2506 Golimumab Biosimilar Now Licensed Across US, Canada, and India
Bio‑Thera Solutions Inc. (SHA: 688177) has expanded its strategic partnership with Intas Pharmaceuticals Ltd., granting...
Biosimilars
Henlius Biotech’s HLX18 Wins NMPA Approval – Nivolumab Biosimilar Enters Phase I Solid Tumor Trials in China
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that HLX18, a recombinant humanized anti‑PD‑1 monoclonal antibody...
Sandoz Forms Global Biosimilars Unit – Metzger-Led Division Targets Accelerated Portfolio Growth
Sandoz (SWX: SDZ), the Swiss generic drug giant, announced the formation of a dedicated global...
FDA Streamlines Biosimilar Development – New Guidance Cuts PK Study Costs by 50%, Accelerates Path to Market
The U.S. Food and Drug Administration (FDA) announced a major policy shift to accelerate biosimilar...
Bio-Thera’s Stelara Biosimilar Usymro Wins UK Approval – Expands European Market Access via Gedeon Richter
Bio-Thera Solutions Ltd (SHA: 688177) announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA)...
Henlius’ HLX11 Wins CHMP Positive Opinion – Perjeta Biosimilar Nears EU Approval for HER2+ Breast Cancer
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the European Medicines Agency’s (EMA) Committee for Medicinal...
Gan & Lee’s Insulin Biosimilars Win CHMP Positive Opinion – Bysumlog and Dazparda Near EU Market Entry
Gan & Lee Pharmaceuticals (SHA: 603087) and its European subsidiary Gan & Lee Europe announced that...
SteinCares Partners with Shilpa Biologicals on Latin America Biosimilar Deal – Regional Commercialization Agreement
SteinCares, a leading specialty healthcare company in Latin America, and Shilpa Biologicals Pvt. Ltd. (SBPL),...
Bio-Thera’s Gotenfia Wins European Approval as Simponi Biosimilar
Bio-Thera Solutions Inc. (SHA: 688177) announced that the European Commission (EC) has approved Gotenfia (BAT2506), its...
Betta Pharma Secures NMPA Approval for Beizeting, First Domestic Pertuzumab Biosimilar in China
Betta Pharmaceuticals Co., Ltd. (SHE: 300558) announced that the National Medical Products Administration (NMPA) has...
Bio-Thera Licenses Keytruda Biosimilar BAT3306 to Avalon for Middle East & North Africa
Bio-Thera Solutions (SHA: 688177) announced a licensing agreement with Avalon Pharma, granting the Saudi Arabia‑headquartered...
Bio‑Thera Solutions Licenses BAT2206 Stelara Biosimilar to Gedeon Richter in $110M Deal
Bio‑Thera Solutions Inc. (SHA: 688177) announced a licensing agreement granting Gedeon Richter Plc. commercialization rights...
Henlius’s HANBEITAI Bevacizumab Biosimilar BLA Accepted by FDA for Multiple Solid Tumors
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the U.S. Food and Drug Administration (FDA)...
Boan Biosimilar Prolia Wins Bolivia Approval, Targets Global Markets
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that BA6101, its biosimilar version of Amgen’s...
Boan Biotech Ships First Batch of Boyoujing Aflibercept Biosimilar in China
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that the first commercial batch of its...
Henlius HLX14 Denosumab Biosimilar NDA Accepted by China CDE
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the National Medical Products Administration’s Center for...
Boan Biotech’s Boyoujing Aflibercept Wins NMPA Approval for Retinal Diseases
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that its self‑developed Aflibercept Intravitreal Injection (Boyoujing)...
Henlius’ POHERDY (HLX11) Receives Full FDA Approval for All Pertuzumab Indications
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that its pertuzumab biosimilar POHERDY (clinical name HLX11)...
EirGenix Secures $152 M Licensing Deal for EG1206A Breast‑Cancer Biosimilar from Sandoz
EirGenix Inc. (TPE: 6589) announced a second, worldwide exclusive licensing agreement with Sandoz AG (SWX:...
Shanghai Henlius Biotech Secures UK MHRA Approval for Denosumab Biosimilars BILDYOS & BILPREVDA
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the United Kingdom’s Medicines and Healthcare Products...