Meeting the Challenges of Integrating Biosimilars in the Healthcare Treatment Paradigm

A continuing medical education activity provided by NAMCP and AAMCN

This activity is an archive of the live session from the 2021 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 June 1, 2021 – August 1, 2022
 

Instructions for CME/NCPD: 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 activity is supported by educational grants from
Sandoz Inc., a Novartis Division.

Description:
Biosimilar products are biologic products that are highly similar to already approved biologic drugs developed for various indications. While biosimilars have some differences compared with their reference products, they are mandated to produce identical similarity from their reference biologics in terms of clinical safety and efficacy. As such, these biosimilar products promise to foster unprecedented access to a wide range of life-saving biologics while ensuring a rise in healthcare access and market sustainability. Biosimilar products also need to include supporting clinical and non-clinical data in certain situations where comparability data is insufficient in assuring positive drug interchangeability.

Biosimilars are expected to have a significant impact on healthcare as they revolutionize the treatments of many disease states. According to a current market forecast, global sales of biosimilars will exceed $19 billion by 2023, up from just $2.5 billion in 2017, driven by their cost-effectiveness and the patent expiration of a number of biologics. Biosimilars have the potential to reduce healthcare costs and expand patient access to biologic therapies. With biosimilars becoming more prevalent there are still a unique set of challenges for regulators, clinicians, payers, and patients. Some of these challenges show the need for better clinical practice guidelines to direct the use of biosimilars and the interchangeability of these products compared with their biologic originator drugs.

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. Physicians and other healthcare providers are the most important stakeholders for biosimilar acceptance and 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. Clinicians and physicians are now starting to use their knowledge to make informed and appropriate decisions, so patients understand the biosimilar benefits, limitations, core concepts and the accessibility. These goals allow for effective strategies to be put into place that will help overcome potential challenges within the treatment and management plans for biosimilar use.

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

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

  • Discuss the types of clinical trials used for regulatory approval of biosimilars using currently available oncology biosimilars as an example

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

  • Identify the clinical challenges and barriers regarding the use of oncology biosimilars when incorporating into treatment plans

  • Examine communication efforts that have improved patient knowledge about the use of biosimilars and encouraged their participation in the shared decision-making process

     

Faculty: Sanjiv S. Agarwala, MD
Professor
Temple University School of Medicine

Disclosure:

Dr. Agarwala has no financial relationships with ineligible companies to disclose.
  Planning Committee:
Bill Williams, MD has no financial relationships with ineligible companies to disclose.
Jeremy Williams has no financial relationships with ineligible companies to disclose.
Jacqueline Cole, RN, MS, CMCN has no financial relationships with ineligible companies to disclose.

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

Accreditation & Designation
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the National Association of Managed Care Physicians (NAMCP) and American Association of Managed Care Nurses (AAMCN). The National Association of Managed Care Physicians is accredited by the ACCME to provide continuing medical education for physicians.

NAMCP designates this enduring material for a maximum of 1 AMA PRA Category 1 credit(s)TM. 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 nursing continuing professional development 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 nursing continuing professional development.

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

This activity is supported by educational grants from
Sandoz Inc., 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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