INTRODUCTION TO BIOSIMILARS: A Science, Regulatory and Commercial Overview

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Release Date: Nov 4, 2013          Expiration Date: Nov 4, 2014

Educational Objectives

At the conclusion of this activity, participants should be able to demonstrate the ability to:

  • Define biosimilars and identify the key differences between biosimilars and generics
  • Describe the science involved in producing biologics and biosimilars
  • Explain the regulatory pathways and FDA requirements for biosimilar approval
  • Outline Medicare’s approach to reimbursement
  • Summarize clinical data for the first cancer biosimilar in the United States