The U.S. Food and Drug Administration (FDA) has accepted Bio-Thera's Biologics License Applications (BLA) for BAT2206 as an interchangeable biosimilar to reference product Stelara ® The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for BAT2206 as a biosimilar to reference product Stelara ® The BAT2206 BLA and MAA are based on a robust analytical, non-clinical and clinical data package comparing BAT2206 to the reference product Stelara ® GUANGZHOU, China , July 24, 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 FDA has accepted the BLA for BAT2206, a proposed interchangeable biosimilar to Stelara ® (ustekinumab) seeking a commercial license in the United States of America . In addition, Bio-Thera also announced that the EMA has accepted the MAA for BAT2206 seeking a commercial license in the European Union (EU). A Biologics License Application seeking approval for BAT2206 is also currently under review by the China National Medicinal Product Administration (NMPA).
"The acceptance of both the FDA BLA and the EMA MAA for BAT2206 marks a milestone for Bio-Thera as it is the first ustekinumab biosimilar developed by a Chinese company to be submitted to the FDA or EMA for approval," said Dr. Shengfeng Li , Founder and CEO of Bio-Thera Solutions. "Bio-Thera is committed to helping patients ar.