Although biosimilars have been available in Europe for more than 10 years, the first biosimilar approved for the use in the United States, filgrastim-sndz, was only approved in 2015. Since then, the US Food and Drug Administration has approved several other biosimilars. These drugs have the potential to reduce overall healthcare costs and increase patient access to optimal care, but their introduction into clinical practice also presents a challenge. There are a number of important terms and concepts to understand, including regulatory standards for biosimilar approval; the differences between biosimilars and generics; and the concepts of interchangeability, totality of evidence, extrapolation, and immunogenicity.
Audio-enhanced slide lecture
After completing this activity, participants should be better able to:
- Define biosimilar concepts such as totality of evidence, extrapolation of indications, and interchangeability, and discuss the current best practice to establish the safety and efficacy of biosimilars
- Identify strategies to overcome potential practical challenges of incorporating biosimilars into clinical practice
- Develop strategies to educate patients about biosimilars
Oncology nurse practitioners, physician assistants, and nurses
In support of improving patient care, Continuing Education Alliance is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
Nursing contact hours: 1.00, which includes 1.00 hours of pharmacology credit
Nurse planner: Katie Zahasky, NP
This program has been reviewed and is approved for a maximum of 1.0 AAPA Category 1 CME credits by the AAPA Review Panel. Approval is valid for one year from the issue date of May 31, 2018. Participants may submit the post-test at any time during that period.
This program was planned in accordance with AAPA CME Standards for Enduring Material Programs and for Commercial Support of Enduring Material Programs.
This activity is supported by an educational grant from Sandoz Inc., a Novartis Division, and Merck & Co, Inc.
Practicing Clinicians Exchange gratefully acknowledges Miller Medical Communications, LLC, for their contribution as educational partner for this program.
The opinions or views expressed in this CE/CME activity do not necessarily reflect the opinions or recommendations of Continuing Education Alliance, Practicing Clinicians Exchange, Miller Medical Communications, LLC, the AAPA, or any educational supporter.
All faculty and planners participating in continuing education activities sponsored by Continuing Education Alliance are expected to disclose to the audience any significant support or substantial relationships with providers of commercial products and/or devices discussed in this activity and/or with any commercial supporters of the activity. In addition, all faculty are expected to openly disclose any off-label, experimental, or investigational use of drugs or devices discussed in this activity. The faculty and planning committee have been advised that this activity must be free from commercial bias, and based upon all the available scientifically rigorous data from research that conforms to accepted standards of experimental design, data collection, and analysis.
Dr Crawford: advisor: AstraZeneca, Dova, Merck, Pfizer; data safety and monitoring board: Beyond Spring, Celgene, G1 Therapeutics, Janssen, Merrimack, Mylan, Roche; principal investigator/institutional research funding: Amgen, AstraZeneca, Bayer, Genentech.
The Planning Committee for this activity included Ruth Cohen of Continuing Education Alliance; Lyerka Miller, PhD, CHCP, Maria DelCegno, and Melanie Spurgeon of Miller Medical Communications, LLC; and Mark Christiansen, PhD, PA-C, of the University of the Pacific. The members of the Planning Committee have no significant relationships to disclose.
Participants wishing to earn CE/CME credit must:
- Watch and listen to the presentation and study the program slides
- Relate the content material to the learning objectives
- Complete the post-test and evaluation form online
Successful completion of the post-test is required to earn CE/CME credit. Successful completion is defined as a cumulative score of at least 70%.
The estimated time to complete this activity is 1.00 hours.
Release date: May 31, 2018
Expiration date: May 31, 2019
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