Latebreakers: R.Ph.s' power is at stake over biogeneric approval, warns USP leader

October 22, 2007

If biogenerics are approved as biosimilars, pharmacists won't have the power to substitute them, warns head of USP

Pharmacists should closely watch the debate now going on in Congress over what kind of a regulatory pathway should be set up to allow the approval of biogenerics. So warns Roger Williams, M.D., president and CEO of the United States Pharmacopeia. The reason is that two approaches are being considered-one of biosimilars, the other of interchangeability. "Interchangeable" means the generic product has the same labeling as the innovator product and can be substituted by the pharmacist. "Biosimilars" uses a lesser standard of comparability, which puts the decision of whether to substitute in the hands of the prescriber. So pharmacists won't have the power to substitute biosimilars, warned Williams. "Personally, I think the comparability category is a little goofy," he added. The USP leader was speaking at the annual Schuss lecture at the Arnold & Marie Schwartz College of Pharmacy & Health Sciences in Brooklyn, N.Y., this month.