FDA Accepts sBLA for Interchangeability Designation for Humira biosimilars

Samsung Bioepis Co., Ltd. and Organon & Co. announced today that the US Food and Drug Administration (FDA) has accepted their Supplemental Biologics License Application (sBLA) for review for the biosimilar interchangeability designation of HADLIMA (adalimumab-bwwd), a biosimilar to Humira (adalimumab).