Managing the Introduction of Biosimilars into the US Healthcare System

Activity Preview

Biologics are among the most effective therapies in use today for patients suffering from cancer, rheumatoid arthritis, multiple sclerosis, and other serious conditions. Biosimilars are biologic agents that are designed to mimic the properties of branded biologics (known as reference products). However, there are important distinctions between biosimilars and generic versions of small molecule drugs.

During this online learning activity, the speaker discusses the current status of biosimilars and recent approvals by the FDA, and identifies potential implications of biosimilars for pharmacists working in various practice settings.

 

Learning Objectives

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

  1. Compare and contrast biosimilars, small-molecule generics, and reference biologic agents based on structure, manufacturing and regulation.
  2. Describe the regulatory pathway in the U.S. for biosimilars.
  3. Discuss the experience with biosimilars in Europe.
  4. Identify potential implications of biosimilars for pharmacists working in various practice settings, including indication extrapolation and formulary considerations, product substitution regulations, pharmacovigilance, and transitions of care.

 

Accreditation Information 

The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education (CPE). The following activity is approved for 1.0 contact hour of CPE credit (0.10 CEUs). The ACPE Universal Activity Numbers for this activity are: 0202-0000-16-147-L04-P (pharmacists) and 0202-0000-16-147-L04-T (pharmacy technicians).

Initial Release Date: November 2, 2016
Expiration Date: August 31, 2019
 

To obtain 1.0 contact hour of CPE credit for attending this online learning activity, “Managing the Introduction of Biosimilars into the U.S. Healthcare System,” participants must complete the CPE assessment and evaluation questions.

Participants will need to have a valid pharmacist.com username and password to claim credit. Credit will be awarded upon achieving a passing score of 70% or better. Please visit CPE Monitor for your transcript.

APhA continuing pharmacy education policy provides you with two opportunities to successfully complete this CPE examination. Please note that you will not be permitted to submit the examination a third time.

The current policy of the APhA Education Department is not to release the correct answers to any of our CPE tests. This policy is intended to maintain the integrity of the CPE activity and the test.

The deadline to claim credit for this home study is August 31, 2019.

 

Development

“Managing the Introduction of Biosimilars into the U.S. Healthcare System” is an online continuing education activity for pharmacists and pharmacy technicians developed by the American Pharmacists Association.

 

Speaker

James G. Stevenson, PharmD, FASHP
Professor, Department of Clinical Pharmacy
University of Michigan College of Pharmacy
Ann Arbor, Michigan

                                                                                                                                              

Disclosures

James G. Stevenson, PharmD, FASHP declares financial interests for the following:

Relationship Name of Commercial Interest Received
Consultant Amgen Honorarium
Advisory Board Pfizer Honorarium
Speaker Abbvie Honorarium
President/Employee Visante, Inc. Salary

 

APhA’s editorial staff declare no conflicts of interest or financial interests in any product or service mentioned in this activity, including grants, employment, gifts, stock holdings, and honoraria. For a complete list of APhA staff disclosures, please visit the APhA website at www.pharmacist.com/apha-disclosures.

Conflicts of interest have been resolved through content review by Helen Sairany, PharmD, BCACP, Associate Director of Content Development at the American Pharmacists Association. 

 

Target Audience

Pharmacists and Pharmacy Technicians

 

ACPE Activity Type

Knowledge-based

 

Learning Level

Level 2

 

Activity Fee

This online learning activity is free to APhA members as an exclusive member benefit for 30 days after release. Thereafter, nonmembers can purchase this home-study at a cost of $129.

 

System Requirements

Windows
Windows XP, Windows 2003 or Windows Vista
Display resolution of 800x600 or higher
Microsoft Internet Explorer 6.0 SP1 or later, Firefox 2.0 or later, or Google Chrome 1.0
For Firefox and Chrome, Silverlight 1.0 or later
Windows Media Player 9.0 or later
Broadband Internet connection (256 Kbps or more)
No network blocks or filters that disable streaming media

Mac
Mac OS X 10.5 or later
Safari 2.0.4 or later (or Firefox 2.0 or later) Silverlight 1.0
Broadband Internet connection (256 Kbps or more)
No network blocks or filters that disable streaming media.

Credit Information

Activity Number Credit Amount Accreditation Period
ACPE# 0202-0000-16-146-H04-P 0.05 CEUs August 31, 2016 - August 31, 2019
ACPE# 0202-0000-16-146-H04-T 0.05 CEUs August 31, 2016 - August 31, 2019
ACPE# 0202-0000-16-147-H04-P 0.1 CEUs October 19, 2016 - October 19, 2019
ACPE# 0202-0000-16-147-H04-T 0.1 CEUs October 19, 2016 - October 19, 2019