Regulation of Generic Pharmaceutical and Biosimilar Products

RGA 6245 4 Quarter Hours
Course Level CPS - Graduate
Description Describes the contrasting history and implementation of generic drug and biologic legislation in the U.S. market. Explores the specific technical differences between drug and biologic products and highlights areas where regulatory approval of generic products must differ between the two categories. Offers students an opportunity to better understand how the nonclinical and clinical development programs of generic drug and biologic products are constructed. Examines the relatively advanced state of the regulatory paradigm for biosimilars in the European Union.


Students should refer to the CPS Prerequisite Table for course prerequisite and corequisite information.


Course Sections

There are no current sections scheduled for this course. Undergraduate course numbers changed beginning with the Fall 2016 term. Please make sure you are using the current course number.
Next Term Starts
  • Winter Graduate
    Jan 8, 2018 (6- and 12-week classes)
    Feb 19, 2018 (6-week classes)

Academic Calendar

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