WASHINGTON, DC- On Tuesday, May 19, 2015, ASBM met with Executive Branch officials to discuss the need for clear naming of biosimilars.
In attendance were officials from the Administration’s Office of Management and Budget (OMB), its Office of Information and Regulatory Affairs (OIRA), the National Economic Council (NEC), and the Department of Health and Human Services (HHS). ASBM was represented by its Chairman, pediatric rheumatologist Dr. Harry Gewanter; and its Executive Director, Michael S. Reilly.
Mr. Reilly described ASBM’s membership, and activities, and Dr. Gewanter provided a clinical perspective on the use of biologic medicines, focusing on the need for clear identification, tracking, and communication.
Dr. Gewanter praised the FDA’s use of distinguishable naming in its first biosimilar approval of Zarxio (filgrastim-sndz), calling the differentiating suffix “helpful”. Dr. Gewanter noted its similarity to the World Health Organization’s (WHO’s) own proposal for distinguishable naming, the Biological Qualifier (BQ)-in which a biosimilar’s International Nonproprietary Name (INN) would consist of a suffix of random letters appended to the INN of its reference product. Gewanter, who recently participated in the WHO’s 60th Consultation on International Nonproprietary Names in April, praised the WHO’s international approach to clear naming: “We need a clear label and INN is a good choice because the issue is a global issue.”
Mr. Reilly echoed the need to find a global, rather than local, solution to the issue of biosimilar naming, praising the WHO’s approach and emphasizing that transparency in naming was key to successfully building physician confidence in biosimilars.