Roughly three-quarters of pharmacists said they would feel confident or very confident substituting an interchangeable biosimilar for its branded biologic counterpart if the two products share the same nonproprietary name.
Alexandria, Va., Feb. 27, 2015 —
Roughly three-quarters of pharmacists said they would feel confident or very confident substituting an interchangeable biosimilar for its branded biologic counterpart if the two products share the same nonproprietary name, according to a survey published in the Academy of Managed Care Pharmacy’s (AMCP’s) Journal of Managed Care & Specialty Pharmacy (JMCP).
Conversely, only about 25 percent of pharmacists would feel as confident if the products had different nonproprietary names, according to the survey conducted by consulting firm Xcenda, an AmerisourceBergen company, and published in the March issue of JMCP.
“The Food and Drug Administration should heed these survey results of frontline practitioners — that the naming convention will play a pivotal role in substitution practices for interchangeable biosimilars,” said ACMP CEO Edith A. Rosato, RPh, IOM. “Public health and the public interest will be best-served if biosimilars and their branded biologic counterparts share the same nonproprietary name.”
At least one biosimilar agent is expected to launch in the U.S. in 2015, but the naming convention has not yet been determined and a heated debate continues over whether a biosimilar should share the same nonproprietary name as its reference product.
The survey aims to shed light on the impact of a biosimilar naming convention on pharmacists’ confidence in substituting interchangeable biologics. Most pharmacists have the highest level of confidence of substitution only when the interchangeable biosimilar and reference product share the same active ingredient or nonproprietary name, the study found.
The findings also indicate that pharmacists will require substantial education on biosimilars and interchangeable biosimilars prior to the launch of the first U.S. product. Education should focus on three areas: (1) instances where substitution is allowed according to FDA approval — i.e., as a biosimilar or interchangeable biologic, (2) appropriate recording of biologic dispensed for pharmacovigilance efforts, and (3) notification requirements driven by specific state laws.
The imminent entry of biosimilars into the U.S. market highlights the need to carefully evaluate current processes of identification, reporting and recording of the biological products dispensed. The results of this survey indicate that the ultimate decision on the naming convention for biosimilars may influence dispensing pharmacists, with the majority of respondents being most comfortable with biosimilars having the same nonproprietary name as the reference biologic.
The survey was designed and fielded by Xcenda in collaboration with AMCP, the American Pharmacists Association and the American Society of Heath-System Pharmacists. To view the survey study, please visit