GUANGZHOU, China, June 3, 2024 /PRNewswire/ -- Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for Avzivi® (bevacizumab), a biosimilar monoclonal antibody referencing AVASTIN®. The CHMP's positive opinion will now be referred to the European Commission, which will decide whether to grant marketing authorization for Avzivi®.
GUANGZHOU, China and BAD VILBEL, Germany, May 28, 2024 /PRNewswire/ -- Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and global specialty, generic and consumer healthcare medicines company STADA Arzneimittel AG have reached an exclusive commercialization and license agreement for BAT2506, a biosimilar candidate to Simponi® (golimumab).
BTS Receives IND Clearance From FDA to Initiate a Phase II Study for BAT8006
GUANGZHOU, China and SAN JOSÉ, Costa Rica, March 18, 2024 /PRNewswire/ -- Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing innovative therapies and biosimilars, and SteinCares, one of Latin America's leading specialty healthcare companies, announced today a new licensing agreement for two biosimilars under which SteinCares will have exclusive rights to distribute and market Bio-Thera's pharmaceuticals in Brazil and the rest of the region.
Bio-Thera Solutions Announces Initiation of Phase IB / IIA Clinical Trial for BAT6026
GUANGZHOU, China, Dec. 7, 2023 /PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, today announced that the United States Food and Drug Administration (FDA) has approved Avzivi® (bevacizumab-tnjn), a biosimilar referencing Avastin®. Avzivi® is Bio-Thera's second USFDA approved product and is the second biosimilar researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA approval in the United States.
Bio-Thera Solutions` Biologic Avzivi (bevacizumab) Receives Approval in the U.S.
FDA Approves Bio-Thera’s Biosimilar of ACTEMRA
GUANGZHOU, China, Oct. 8, 2023 /PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, announced that its partner Biogen recently received notification from the United States Food and Drug Administration (FDA) on the approval of TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA. The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.