Henlius Biotech Secures European Commission Approval for Poherdy Biosimilar to Roche’s Perjeta
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced it has received marketing authorization from the European...
Biosimilars
Shandong Boan Biotech Advances First-in-China Anti-CD25 Antibody BA1106 into Phase II NSCLC Trial in Combination with Nivolumab Biosimilar BA1104
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that the Center for Drug Evaluation (CDE)...
Roche Q1 Sales Rise 6% Driven by Innovative Medicines as China Expansion and Diagnostics Recovery Offset Currency Headwinds
Roche AG (SWX: ROP, OTCMKTS: RHHBY) reported first-quarter 2026 group sales of CHF 14.7 billion...
Mabwell Bioscience Secures Second NMPA Approval for Denosu, China’s First Xgeva Biosimilar, Expanding Indication to Bone Metastasis and Multiple Myeloma
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced a second indication approval from China’s...
Shanghai Henlius Biotech Launches Phase I Trial for HLX05-N Cetuximab Biosimilar in Metastatic Colorectal Cancer
Shanghai Henlius Biotech, Inc. (HKG: 2696), a leading Chinese biopharmaceutical company, announced it has received...
Henlius Biotech Doses First Patient in Phase I Trial for HLX319, a Biosimilar to Roche’s Phesgo
Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the dosing of the first subject in...
Henlius Biotech Secures Two New NMPA Approvals for Hanlikang – Expands Rituximab Biosimilar into DLBCL Combination Therapies
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has granted...
Fosun Pharma Secures NMPA Approval for Phase I Trial of HLX319, Biosimilar to Roche’s Phesgo for HER2-Positive Breast Cancer
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced it has received approval...
Teva Secures FDA Approval for Prolia Biosimilar Ponlimsi, Advances Xolair Copycat Through Regulatory Channels
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) has announced FDA marketing approval for Ponlimsi, its biosimilar...
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...
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...