The Future Has Arrived: Biosimilars – Neither Bioexact Nor Biobetter

Description

Five biosimilars of four biologic products have been approved in the US since March 2015. A market research forecast of worldwide pharmaceutical sales predicts that, in 2020, 11 of the top 20 products will be biologics. The Biologics Price Competition and Innovation (BPCI or "Biologics") Act of 2009 opened the door for faster approval of follow-on biologic products by creating a framework for an abbreviated licensure pathway. FDA issued final guidances for industry on biosimilars in 2015 and 2016 and posted draft guidances on nonproprietary naming of biologic products and on biosimilar interchangeability in January 2017. This presentation highlights the differences between biosimilars and either conventional generic drugs or bio-original products, the legal requirements of biosimilars, and will outline the biosimilar approval process. The session's content assists health care organizations and providers determine the role of biosimilars on formularies and the implications of incorporating biosimilars into clinical practice.

Pharmacist Learning Objectives

At the completion of this activity, participants will be able to:
1. List five differences between generic drugs and biosimilar agents related to their chemical structure, manufacturing process, and regulatory evaluation.
2. Explain the differences among reference, biosimilar, interchangeable, noninnovator, and follow-on biologic agents.
3. Describe the FDA approval process of originator, biosimilar, and interchangeable biologic products.
4. State five concerns formulary committees, pharmacists, or pharmacy technicians should consider with regard to biosimilar substitution.

Technician Learning Objectives

At the completion of this activity, participants will be able to:
1. List five differences between generic drugs and biosimilar agents related to their chemical structure, manufacturing process, and regulatory evaluation.
2. Explain the differences among reference, biosimilar, interchangeable, noninnovator, and follow-on biologic agents.
3. Describe the FDA approval process of originator, biosimilar, and interchangeable biologic products.
4. State five concerns formulary committees, pharmacists, or pharmacy technicians should consider with regard to biosimilar substitution.

 
 
 
Speakers:
Francine
Francine Goodman,
National Clinical Pharmacy Program Manager
Department of Veterans Affairs
 
Learning Level: Level 1
Track: Clinical Patient Care
Session Time Slot(s): 
Date: 
Tuesday, September 12
Time: 
3:15 PM - 4:15 PM
Room: 
Rosen Shingle Creek - Suwannee 11/12
ACPE Pharmacist: 0202-0000-17-174-L04-P
CEUs Pharmacist: .1
ACPE Pharmacy Technician: 0202-0000-17-174-L04-T
CEUs Pharmacy Technician: .1
Activity Type:
Knowledge-based