The FDA has decided that biosimilar medications must have unique naming features, distinguishing them from brand-name biologics in a move to improve patient safety, according to a STAT news report.
Five things to know:
1. The FDA issued a draft guidance that biosimilars should have four-letter suffixes added to their names. Brand-name biologics would not need the suffix.
2. With the decision, the FDA is trying to settle a long-standing debate over the best approach for naming biosimilars. Brand-name drugmakers have long argued that biosimilars need to be differentiated to make it easier to track side effects and protect patient safety. On the other hand, generic drugmakers argue that having different names for biosimilars may confuse prescribers and pharmacists. Generic drug companies also refute brand-name companies' claims, arguing that side effects are easily tracked through product codes.
3. The decision was unexpected, according to the report. About two years ago, the FDA issued a guidance that indicated suffixes would not be added.
4. Adding distinguishing features to the names of biosimilars was quickly opposed by the head of the Biosimilars Council, who told STAT the "FDA’s current requirement of suffixes presents a significant, artificial barrier to biosimilars that is misaligned with the agency's own Biosimilars Action Plan and the Trump administration's commitment to lowering drug prices for America's patients."
5. In announcing the change, FDA Commissioner Scott Gottlieb, MD, said "Some have argued that the addition of a distinguishing suffix could serve as a barrier to the use of biosimilar products and brisk competition. We strongly believe in the ability of biosimilars to promote competition, lower prices and foster greater access."