FDA interchangeability designation policies and lack of clear policy on demonstrating interchangeability, coupled with Medicare reimbursement policies and ill-defined manufacturing practices are hindering the acceptance of biosimilars in the U.S. marketplace, a Harvard Medical School health economist says.
Richard G. Frank, PhD, former deputy assistant secretary for planning and evaluation at HHS posits in a perspective for the New England Journal of Medicine that biosimilars will fall short on the ability to offer cost savings to the country’s health system. Frank said only about 3 percent of U.S. biologic drug spending faces legitimate competition from biosimilars. Further, spending on biologic drugs increases an average of 10 percent each year.
Frank attributes the results to several factors. In particular, physicians lack familiarity with the products and thus, are hesitant to prescribe. This hesitation in part may come from, “The FDA’s use of 4-letter suffixes appended to the names of biosimilars may give prescribers the undue impression that the clinical effects of a biosimilar could have a meaningful difference from those of the reference drug, and ‘Perceived differences between competing products weaken price competition,'” according to a Center for Biosimilars report.
Additionally, Frank said FDA had not finalized its requirements for demonstrating that interchangeability, which is required for substitutions of the reference drug at the pharmacy level.
“ … the FDA requires that equivalent clinical results occur within the same patient if the biosimilar replaces the reference product. The FDA has not been clear about whether this requirement involves meeting an additional standard or producing more data. Conducting extra clinical studies is a very expensive activity, so clarity on this point is important.”
