• European Commission grants approval for Gotenfia®, a golimumab biosimilar to Simponi® that was developed by Bio-Thera and will be marketed by STADA• Launch preparations are underway to bring the second approved golimumab biosimilar to patients acro...
View DetailsGuangzhou, China– July 25, 2024 – Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical companydeveloping a pipeline of innovative therapies and biosimilars, today announced thatdosing has recently begun in an integrated Phase I ...
The U.S. Food and Drug Administration (FDA)has accepted Bio-Thera’s Biologics License Applications (BLA) for BAT2206 as aninterchangeable biosimilar to reference product Stelara® The European Medicines Agency (EMA) hasaccepted the Marketing Authoriza...
CHMP positive opinion is based on a robustanalytical, non-clinical and clinical data package comparing Avzivi® to thereference product Avastin® Guangzhou, China– June 3, 2024 –Bio-Thera Solutions, Ltd. (688177:SH), a commercial-stage biopharmaceutica...
