USP Dukes It Out With Senate, Administration Over Biologics Monographs

The United States Pharmacopeia, backed by generic drug makers and multiple pharmacist groups, has launched a full-scale effort to quash a proposal by the Senate health committee and Trump administration to remove biologics from USP monograph standards, arguing the proposal would reduce confidence in biosimilars. FDA weighed in Wednesday (June 12) by publishing a Q&A with an agency official who takes the opposite stance as USP and argues in favor of removing biologics from the monograph standards as a way...