On September 8, 2026, Bristol-Myers Squibb Company, E. R. Squibb & Sons, L.L.C., (collectively, “BMS”) and Ono Pharmaceutical Co., Ltd. (“Ono”) filed a BPCIA complaint in the U.S. District Court for the District of Delaware against Amgen Inc. (“Amgen”), alleging that Amgen’s proposed nivolumab biosimilar, ABP 206, will infringe seven…
On June 30, 2026, Orca Bio announced that the U.S. Food and Drug Administration (“FDA”) approved TREGZI™ for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host-free survival, in the treatment of adults with hematological malignancies. TREGZI™…
On May 29, 2026, Boan Biotech announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for BA6101 (denosumab; injection 60 mg) and BA1102 (denosumab; injection 120 mg), referencing Amgen’s PROLIA® (denosumab) and XGEVA® (denosumab), respectively. According to Boan Biotech, the submission is…