A coalition of organizations representing specialist physicians and individual physicians have authored a letter to U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg calling on the agency to allow biosimilar drug products to have “distinguishable nonproprietary names.”
Noting that biosimilars will not be identical to the reference products, the organizations contend that (i) “[d]istinct nonproprietary names will help to alert physicians that each product, while safe and effective, may differ slightly”; (ii) “allowing physicians to know the exact product that they are prescribing will increase confidence, thus encouraging more robust utilization of biosimilars than may develop without this transparency”; (iii) 61 percent of physicians prescribing biologics and biosimilars in Europe “believed that if two products shared an International Nonproprietary Name (INN), they were approved for all of the same indications,” which “is not necessarily the case”; (iii) “distinguishable names will help prevent inappropriate pooling of adverse events”; and (iv) “FDA’s decision on interchangeability between indications may largely be rendered moot once biosimilars enter the U.S. marketplace, if the biosimilar shares a nonproprietary name with the reference product.”
Among the organizations signing the letter were the Alliance for Patient Access—identified by The Wall Street Journal as a group that is “largely funded by the pharmaceutical industry”—American Academy of Dermatology, American College of Rheumatology, and Association of Black Cardiologists. Brand-name drug makers and biotechnology companies reportedly endorse this position on biosimilar naming as well. See The Wall Street Journal, August 15, 2014.