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Biosimilar Naming Conventions: Pharmacist Perceptions And Impact On Confidence In Dispensing Biologics, Daniel M. Tomaszewski
Biosimilar Naming Conventions: Pharmacist Perceptions And Impact On Confidence In Dispensing Biologics, Daniel M. Tomaszewski
Pharmacy Faculty Articles and Research
BACKGROUND: The approval of the first biosimilar in the United States has placed increased pressure on the FDA to provide guidance on the naming convention that will be assigned to current and future biosimilars. The release of the FDA draft guidance on nonproprietary naming of biosimilars in August 2015 established a naming convention for all biologic products, including biosimilars. However, the draft guidance is nonbinding while the FDA continues to receive input from stakeholders, and it does not address the naming convention that will be used for products designated as interchangeable biologics.
OBJECTIVES: To (a) determine pharmacist perceptions …