Overcoming Challenges in the
Emerging Biosimilar Landscape

A continuing medical education activity sponsored by NAMCP and AAMCN.

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

This activity is valid from June 15, 2017 to August 1, 2018

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 educational activity is supported by educational grants from
Boehringer Ingelheim Pharmaceuticals and Sandoz, A Novartis Division

Description:
A biosimilar is a biologic drug that is developed to be highly similar, but not identical, to an existing biologic. The FDA looks at biosimilars as a biological product that is similar to a US 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. Biologic agents have revolutionized the treatment of many diseases, including breast cancer, lung cancer, non-Hodgkin’s lymphoma, hepatitis, 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.

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

  • Identify the safety and efficacy of biosimilars in relation to biologics and generic pharmacologics

  • Assess the clinical data and evidence for current and emerging biosimilars that demonstrate biosimilarity compared to the branded products

  • Evaluate clinical implications of the manufacturing processes used to produce biosimilars in regards to the complexity and regulatory pathways

  • Discuss the different therapeutic areas that rely on biologics and how biosimilars can broaden treatment options in relation to safety and effectiveness

  • Discuss the potential cost savings associated with current and emerging biosimilars and how this could affect improved access for patients
     

Faculty: Steven R. Feldman, MD, PhD
Professor of Dermatology
Department of Dermatology
Wake Forest University School of Medicine

Disclosure:

Dr. Feldman is the on the speaker's bureau for AbbVie, Celgene, Janssen, Leo Pharma, Inc, Lilly, Novartis, and Taro. He services as a consultant to AbbVie, Advance Medical, Caremark, Celgene, Galderma, Gerson Lehrman Group, Guidepoint Global, Janssen, Kikaku, Leo Pharma, Inc, Lilly, Merck, Mylan, Novartis, Pfizer, Qurient, Sanofi, Suncare Research and Xenoport. He receives grant support from AbbVie, Celgene, Galderma, Janssen, Pfizer, Qurient, Sanofi and Taro. Additionally, he receives royalties from Informa, UpToDate and Xlibris. He is a majority stock owner in Medical Quality Enhancements Corporation and is the Founder, stockholder and Chief Technology Officer for Causa Technologies. His presentation has been peer reviewed.
 
  Planning Committee:
Bill Williams, MD has no real or perceived financial relationships to disclose.
Katie Eads has no real or perceived financial relationships to disclose.
Will Williams has no real or perceived financial relationships to disclose.
Jacquelyn Smith, RN, BSN, MA, 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 to provide continuing medical education for physicians.

NAMCP designates this enduring material for a maximum of 1 AMA PRA Category I creditsTM. Each physician should claim credit commensurate with the extent of their participation in the activity.

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 educational activity is supported by educational grants from
Boehringer Ingelheim Pharmaceuticals and Sandoz, A Novartis Division

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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