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October 28, 2015
Survey: Pharmacists Want More Distinguishable Names for Biologics, Biosimilars
Washington, D.C.—Pharmacists strongly support distinguishable names for biologics and biosimilars, as well as more transparency in labeling, according to a new survey. The Alliance for Safe Biologic Medicines (ASBM) recently released the results of a survey of 401 U.S. pharmacists, with 68% agreeing that the FDA should require distinct nonproprietary names for all biologics, including biosimilars. Another 23% disagreed and 8% said they had no opinion. “This survey reinforces what ASBM has been hearing from pharmacists through our continuing education programs and makes it clear that they prefer distinguishable names and more complete specific approval labeling for biologics than is currently called for by the FDA,” said Michael Reilly, ASBM’s executive director. The 15-minute Web-based survey of U.S. pharmacists was sponsored by ASBM and administered by Industry Standard Research, LLC. Participants were all either retail or hospital/health system pharmacists who have practiced for more than a year and dispense biologic medicines. Participants received a stipend from the advocacy group. Asked, “If two biologic medicines have the same nonproprietary scientific name, does this suggest to you or imply that a patient could be safely switched from a reference biological medicine to its biosimilar during a course of treatment and expect the same result as with either of the products?” Fifty-eight percent of the respondents agreed. In addition, 55% said “yes” to the following question: “If two biologic medicines have the same nonproprietary scientific name, does this suggest to you the medicines are approved for the same indications?” As for the whether the scientific name should have a suffix that identifies the manufacturer or not, 77% of the pharmacists said they would prefer the manufacturer suffix. “These results are not surprising,” said Ronald P Jordan, RPh, dean at Chapman University School of Pharmacy in Orange County, CA and former president of the American Pharmacists Association (APhA). “Pharmacists know that their ability to improve patient outcomes and safety is hampered, unless they can clearly distinguish similar biologic medicines from one another. Distinguishable names are essential for tracking, reporting and discussion of specific product indications, contraindications or any potential adverse responses. To protect the hope these new agents offer in terms of better care and lower costs, clearly associating use and results accurately with each source, requires precise product identification.” As for the labeling of biosimilars, the ASBM survey indicates pharmacists want greater transparency than the FDA currently requires. Asked to rate from 1 to 5 the importance of certain information being included on a biosimilar's label, here are the percentages of respondents choosing a “4“ or a “5” for the following: • 81%: Identifying the product as a biosimilar; • 88%: Whether or not the biosimilar is interchangeable with (safely substitutable for) its reference product; • 76%: In which approved indications the biosimilar was studied, and for which approval was based on extrapolation from studies in other indications; • 69%: Distinguishing the source of data provided (originator product or biosimilar). None of this information is currently present on the label of the only approved U.S. biosimilar, Zarxio (filgrastim-sndz), ASBM pointed out. “We hope these survey results positively inform the FDA as it drafts its upcoming labeling guidance,” said Jordan, who recently presented some of the survey data at the World Health Organization’s 61st Consultation on International Nonproprietary Names (INN) in Geneva, Switzerland.
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