The FDA announced a new draft guidance that would streamline unnecessary clinical pharmacokinetic (PK) testing when scientifically justified. This draft guidance provides updated recommendations to prospective biosimilar applicants seeking to use data from a comparator product approved outside the U.S. as evidence that a proposed product is biosimilar to the U.S.-licensed product. The recommendations describe scenarios in which a biosimilar applicant may use clinical data from outside the U.S. without additional data from a three-way PK study.
