Understanding the Ever-Changing World of Biosimilars

A continuing medical education activity sponsored by NAMCP and AAMCN.

This activity is an archive from the live session at the 2017 Fall Forum. If you participated in
the live session, you are not eligible for continuing education credits from this archive.

This activity is valid from January 10, 2018 to January 31, 2019

Instructions for CME/CNE: Complete the pre-test, listen to the audio and view the slides, complete the post test, complete the evaluation form and hit submit. You will be asked to enter your name and email address on the pre-test, evaluation and post-test. If you close your internet browser without completing the post test, you will have ONE more opportunity to complete. A score of 70% must be achieved on the post test to receive continuing education credits. If you do not pass the post test after two attempts, you will not be eligible to try again. Once you complete the evaluation form and score 70% or higher on your post test, you will automatically be given your certificate.

To print or save your certificate, you will need to click on the “download” button and either print or save.

 

Audience: This activity is intended for healthcare professionals practicing in managed care environments.

This presentation is supported by an educational grant from
Teva Pharmaceuticals

Description:
A biosimilar is a biologic drug that is developed to be highly similar, but not identical, to an existing biologic. They are a large molecule that is typically derived from living cells and can be used in the prevention, diagnosis, and/or treatment of the disease. Biologic agents have revolutionized the treatment of many diseases, including several cancers, inflammatory bowel disease (IBD), rheumatoid arthritis, and many more. Now, with patents continuing to expire on these first biologics, biosimilar products are becoming available. These agents are expected to have a significant impact on healthcare but present a unique set of challenges for regulators, clinicians, payers, and consumers. The FDA looks at biosimilars as a biological product that is similar to a U.S. licensed biological product not including minor differences in clinically inactive components, as well as having no clinically meaningful differences between the biological product and the reference product in terms of the safety, efficacy and potency of the product. The development of new biologics may be a big step in effectively treating diseases for which there are currently no cures. Approvals of more biosimilars focused on oncology products, as well as biosimilars for anti-TNF biologics, are anticipated in the later stages of 2017.

Upon Completion of this activity, participants will be able to:

  • EIdentify the safety, efficacy, and characteristics of biologics and biosimilars

  • Assess the clinical trial data for current biologics and emerging biosimilars and the potential cost savings they may provide

  • Explore the developmental process of biosimilars, including the complexities of their production

  • Discuss the barriers for policy considerations on what will drive the decisions to cover biosimilar drugs and how they will be used in a clinical setting

  • Evaluate the bioengineering and regulatory basis of biosimilars by looking at the advantages and risks of their potential use in practice
     

Faculty: Jay B. Wish, MD
Professor of Clinical Medicine
Indiana University School of Medicine
University Hospital

Disclosure:

Dr. Wish serves as a consultant and on the speaker's bureau for Pfizer. His presentation has been peer reviewed for any bias.
 
  Planning Committee:
Bill Williams, MD has no real or perceived financial relationships to disclose.
Jeremy Williams has no real or perceived financial relationships to disclose.
Jacqueline Cole, RN, MS, CMCN has no real or perceived financial relationships to disclose.

NAMCP and/or the presenter has copyright or has received permissions for use of materials provided in this activity.

Accreditation & Designation
The National Association of Managed Care Physicians (NAMCP) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

NAMCP designates this enduring material for a maximum of 1 AMA PRA Category I creditsTM.

The American Association of Managed Care Nurses is accredited as a provider of continuing nursing
education by the American Nurses Credentialing Center’s Commission on Accreditation.

Nurses who complete this activity and achieve a passing score will receive 1 hour in continuing
nursing credit.

This activity has been approved by the American Board of Managed Care Nursing for 1.0 contact hours toward CMCN recertification requirements.

This presentation is supported by an educational grant from
Teva Pharmaceuticals

NAMCP and/or this website does not provide medical advice, diagnosis or treatment. NAMCP does not endorse or imply endorsement of the content on any linked website. This website is to be used as an informational resource. With any health related concern, consult with your physician or healthcare professional.

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