A Framework for Integrating Biosimilars Into the Didactic Core Requirements of a Doctor of Pharmacy Curriculum.

Biologic drugs approved via the abbreviated United States biosimilar approval pathway are anticipated to improve access to medications by addressing increasing health care expenditures. Surveys of health care practitioners indicate that there is inadequate knowledge and understanding about biosimilars; this must be addressed to ensure safe and effective use of this new category of products. Concepts of biosimilar development, manufacturing, regulation, naming, formulary, and inventory considerations, as well as patient and provider education should be included within the doctor of pharmacy (PharmD) curriculum as preparation for clinical practice. Based on these considerations, we propose that PharmD graduates be required to have knowledge in the following domains regarding biologics and biosimilars: legal definition, development and regulation, state pharmacy practice laws, and pharmacy practice management. We link these general biosimilar concepts to the Accreditation Council for Pharmacy Education (ACPE) Standards 2016 and Center for the Advancement of Pharmacy Education (CAPE) Outcomes 2013, and provide example classroom learning objectives, in-class activities, and assessments to guide implementation.