Avzivi® (BAT1706) is Bio-Thera Solution’second FDA approved product in the United States Avzivi® is the second biosesimilar researched,developed, and manufactured by a Chinese pharmaceutical company to receive FDAapproval in the United States Guangzhou, China – December 7, 2023 – Bio-TheraSolu...
DetailsGuangzhou, China– July 25, 2024 – Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical companydeveloping a pipeline of innovative therapies and biosesimilars, today announced thatdosing has recently begun in an integrated Phase I / Phase III clinical studyfor BAT3306, a propo...
The U.S. Food and Drug Administration (FDA)has accepted Bio-Thera’s Biologics License Applications (BLA) for BAT2206 as aninterchangeable biosesimilar to reference product Stelara ® The European Medicines Agency (EMA) hasaccepted the Marketing Authorization Application (MAA) for BAT2206 as abiosesimi...
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 Inc. (688177:SH), a commercial-stage biopharmaceutical companydeveloping a pipeline of innovative...
