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 2016 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 31, 2017 to January 31, 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 an educational grant from
Sandoz, a Novartis Company

Biologic agents have revolutionized the treatment of many diseases, including cancer, diabetes, hepatitis, inflammatory bowel disease, and rheumatoid arthritis. A biosimilar is a biologic drug that is developed to be highly similar, but not identical, to an existing biologic. Although there are minor differences in clinically inactive components, they cannot have a clinically meaningful difference between the biological product and the reference product in terms of the safety, efficacy and potency. Along with their sensitivity and size, biologic medicines are almost always injected into a patient’s body and the way a patient responses to that treatment can depend on how a biologic is made. Since the complexity of biologic medicines is well documented along with their complex production, biosimilars must be determined on the basis of analytical, non-clinical and clinical data to be similar to an original biologic in structural characteristics, safety and efficacy. Small differences with the active ingredient are expected and permitted so long as any such differences are demonstrated not to be clinically meaningful. 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:

  • Analyze the safety and efficacy data of current and emerging biosimilar treatments including novel biologic agents

  • Assess the value of biosimilars including effectiveness, costs, quality, safety and ease of use for the education of the healthcare team

  • Evaluate different payer strategies, including unresolved and emerging issues, with biosimilars and formulary management

  • Explain specific factors that need to be addressed when integrating biosimilars into the medication-use process

  • Compare and contrast the clinical strategies for promoting the safe and effective use of biosimilars

Faculty: Grant D. Lawless, RPh, MD, FACP
Associate Professor of Health Economics & Director, Healthcare Decision Analysis
University of Southern California


Dr. Lawless serves in an advisory capacity to the Patient Access Network Foundation and is a consultant for Dos Vientos Consulting Inc. His presentation has been peer reviewed.
  Planning Committee:
Bill Williams, MD has no real or perceived financial relationships to disclose.
Jacquelyn Smith, RN, BSN, MA, CMCN 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.

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 is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education to physicians.

The National Association of Managed Care Physicians designates this live activity for a maximum of 1 AMA PRA Category 1 Credits™. Physicians should only 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 turn in a validation form will receive up to 1 credit in continuing nursing education.

The American Board of Managed Care Nurses has approved this activity for a maximum of 1 contact hour towards CMCN recertification.

This educational activity is supported by an educational grant from
Sandoz, a Novartis Company

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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