On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing...more
On February 18, 2025, Alvotech and Teva Pharmaceuticals (“Teva”) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, a proposed biosimilar to...more
On January 10, 2025, Teva Pharmaceutical Industries Ltd. and Samsung Bioepis Co., Ltd. announced that they entered into a licensing agreement to commercialize EPYSQLI® (eculizumab-aagh), Samsung’s biosimilar of...more
Originally published in The Journal Record | January 31, 2019. This month, the U.S. Supreme Court issued its opinion in Helsinn Healthcare v. Teva Pharmaceuticals, confirming that private sales of an invention may preclude...more