Expanding the Role of Biosimilars: Key Advances in the Treatment Landscape

A continuing medical education activity sponsored by NAMCP and AAMCN.

This activity is an archive from the live session from the 2019 Spring Managed Care Forum. If you participated in the live session, you are not eligible for continuing education credits from this archive.

This activity is valid from July 1, 2019 to August 1, 2020

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
Sandoz, a Novartis Division

Description:
Biosimilars are biologic drugs that are highly similar to drugs developed for various indications and have no meaningful differences in safety, purity and potency. While biosimilars have some differences compared with their reference products, the differences do not affect efficacy, safety, mechanisms of action, condition or approved indications. 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. The goal of biosimilars is to demonstrate biosimilarity between the proposed biosimilar product and the reference product, although not necessarily interchangeable. To be considered interchangeable, biosimilars require evidence that they have the same clinical result as the reference product. An interchangeable product must also demonstrate that there is no greater risk in switching between the two drugs in terms of safety and efficacy. Biosimilars manufacturers limit the number of times that they conduct expensive and lengthy clinical trials, to potentially lead to faster access to these products, additional therapeutic options, and reduced costs for patients. This allows for better data and key analytics when determining if the biosimilar agent is effective and maintains a level of safety and efficacy. Once a biosimilar is approved for use by the FDA, it can be approved for additional indications (conditions) based on a concept called extrapolation of data. If the data collected on the biosimilar in preclinical work shows the same clinical result as the original product, additional clinical trials do not have to be conducted. Given the constant changes in biosimilars, evidence suggests that clinicians need to be continually educated about the multiple aspects of biosimilars, including the underlying scientific principles, the development and regulatory pathways, how to use them in clinical practice, as well as educating their patients about their value.

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

  • AAnalyze the key considerations on biosimilars, including extrapolation and interchangeability

  • Discuss the clinical data and key analytics for biosimilars by giving real-world examples in clinical practice

  • Assess the safety and efficacy of current and emerging biosimilars in the treatment of oncology

  • Describe biosimilars in an effective manner that supports informed choices and treatment adherence

  • Examine the clinical challenges and barriers regarding the use of oncology biosimilars when incorporating into treatment decisions
     

Faculty: Sanjiv S Agarwala, MD
Professor & Chief
Hematology & Oncology
St Luke’s Cancer Center & Temple University

Disclosure:

Dr. Agarwala has no relevant financial relationships to disclose.
  Planning Committee:
Bill Williams, MD has no relevant financial relationships to disclose.
Jeremy Williams has no relevant financial relationships to disclose.
Will Williams has no relevant financial relationships to disclose.
Jacqueline Cole, RN, MS, CMCN has no relevant 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 (AAMCN) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation (ANCC).

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 hour toward CMCN recertification requirements.

This presentation is supported by an educational grant from
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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