Overview of Biosimilar and Interchangeable Products

Description

In 2010, legislation gave the Food and Drug Administration (FDA) authority to approve and regulate biosimilar products for marketing in the United States. This presentation provides an overview of FDA's general review process in considering biosimilar product development programs, differences between a reference product and a biosimilar product, and other resources for biological product information. Information about the approval pathway for biosimilar products will help participants make thoughtful and critical decisions when considering prescribing or dispensing biosimilar products.

Pharmacist Learning Objectives

At the completion of this activity, participants will be able to:

  1. Identify the changes to the law granting FDA authority to review and license biosimilar products
  2. Define biological products and biosimilar products
  3. Recognize the key terminology related to biosimilar products
  4. Describe FDA's general approach to the development and approval of biosimilar products
  5. Discuss the use of reference products, biosimilar products, and interchangeable products             

Technician Learning Objectives

At the completion of this activity, participants will be able to:

  1. Identify the changes to the law granting FDA authority to review and license biosimilar products
  2. Define biological products and biosimilar products
  3. Recognize the key terminology related to biosimilar products
  4. Describe FDA's general approach to the development and approval of biosimilar products
  5. Discuss the use of reference products, biosimilar products, and interchangeable products      
 
 
 
Speakers:
Keith
Keith Olin, PharmD
Process and Knowledge Management Director
U.S. Food and Drug Administration (FDA)
 
Learning Level: Level 1
Track: Clinical Patient Care
Session Time Slot(s): 
Date: 
Tuesday, October 29
Time: 
2:00 PM - 3:00 PM
Room: 
Hilton Anatole Dallas - Cortez A
ACPE Pharmacist: 0202-0000-19-174-L03-P
CEUs Pharmacist: .1
ACPE Pharmacy Technician: 0202-0000-19-174-L03-T
CEUs Pharmacy Technician: .1
Activity Type:
Knowledge-based