FDA Overview of Biosimilar Products

A 1.5-hour continuing education program for pharmacists, physicians, nurses, nurse practitioners, and physician assistants

Available until February 17, 2019

Full accreditation information and disclosures are available at: http://fdabiosimilars.e-paga.com/

 

Description

Biosimilar products are a new type of biological product. In 2010, legislation gave the Food and Drug Administration (FDA) authority to approve and regulate biosimilar products for marketing in the United States. This course shares information about this important new approval pathway for biosimilar products to help participants make thoughtful and critical decisions when considering prescribing or dispensing biosimilar products. The course provides an overview of FDA’s general review process in considering biosimilar product development programs.

 

Learning Objectives

Upon completion of this activity, participants should be able to:

  1. Identify the changes to the law granting FDA authority to review and license biosimilar products.
  2. Define what biological products and biosimilar products are.
  3. Recognize the key terminology related to biosimilar products.
  4. Describe FDA’s general approach to the development and approval of biosimilar products.

 

Pharmacy Technician Learning Objectives

Upon completion of this activity, participants should be able to:

  1. Define what biological products and biosimilar products are and why they differ from other small molecule drugs.
  2. Define the meaning of a reference and a biosimilar product.
  3. Describe the difference between a generic and a biosimilar drug product.
  4. Describe the FDA’s stepwise approach to the development and approval of biosimilar products.