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.
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.
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
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
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
||Sanjiv S. Agarwala, MD
Temple University School of Medicine
Agarwala has no financial relationships with ineligible
companies to disclose.
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
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
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