STATEMENT OF NEED

The rising costs of cancer therapies place a substantial burden on the healthcare system. Biosimilars are lower-cost biopharmaceutical products with high similarity to reference biologic products. While biosimilars present a cost-effective alternative to expensive biologics, their integration into oncology practice faces challenges due to knowledge gaps regarding their development, regulatory framework, and clinical implementation. Clinicians often express uncertainty about the safety, efficacy, and interchangeability of biosimilars. This monograph provides a comprehensive overview of biosimilars in oncology, addressing key barriers to adoption and offering practical guidance for their implementation in clinical practice.

TARGET AUDIENCE

Oncologists, advanced practice providers, nurses, pharmacists, and other healthcare professionals involved in the treatment of patients with cancer.

LEARNING OBJECTIVES

Upon completion of this activity, participants should be able to

• Define biosimilars and distinguish them from other therapeutic products, including generic drugs, interchangeable biologics, and reference products
• Describe the regulatory framework for biosimilar approval

REGISTRATION

There is a fee of $29.95 to participate in or claim CME/NCPD/CPE/AAPA credit for this activity.

PROVIDED BY

JOINTLY ACCREDITED PROVIDER

In support of improving patient care, i3 Health is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

PHYSICIANS

i3 Health designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.5 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

By providing this information, participants are agreeing to allow i3 Health to share this information with the ACCME.

Physician Assistants/Associates

i3 Health has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 0.5 AAPA Category 1 CME credits. Approval is valid until 3/27/26. PAs should only claim credit commensurate with the extent of their participation.

Nurse Practitioners

The American Academy of Nurse Practitioners Certification Program (AANPCP) accepts AMA PRA Category 1 Credit™ from organizations accredited by the ACCME. Individuals are responsible for checking with the AANPCP for further guidelines.

Nursing Continuing Professional Development

A maximum of 0.5 ANCC contact hours may be earned by learners who successfully complete this nursing continuing professional development activity. This activity has been designated for 0.5 ANCC contact hours of pharmacology credit for Advanced Practice Registered Nurses.

Provider approved by the California Board of Registered Nursing, Provider Number 15824, for 0.5 ANCC contact hours. 

Continuing Pharmacy Education

i3 Health has approved this knowledge-based activity for 0.5 ACPE CE hours. The Universal Activity Number for this activity is JA0008128-0000-25-021-H01-P. Pharmacy CE credits can be submitted to the NABP upon successful completion of the activity and the evaluation by providing your NABP ID and DOB, which must be submitted within 60 days of completion. 

DISCLOSURE OF RELEVANT FINANCIAL INFORMATION WITH INELIGIBLE COMPANIES

i3 Health endorses the standards of the ACCME, ANCC, and ACPE that require everyone in a position to control the content of a CME/NCPD/CPE activity to disclose all financial relationships with ineligible companies that are related to the content of the CME/NCPD/CPE activity. CME/NCPD/CPE activities must be balanced, independent of commercial bias, and promote improvements or quality in healthcare. All recommendations involving clinical medicine must be based on evidence accepted within the medical profession.

A conflict of interest is created when an individual has an opportunity to affect CME/NCPD/CPE content about products or services of an ineligible company with which he/she has a financial relationship, which therefore may bias their opinions and teaching. This may include receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, stocks, or other financial benefits.

i3 Health will identify, review, and mitigate all relevant financial relationships that speakers, authors, or planners disclose prior to an educational activity being delivered to learners. Disclosure of a relationship is not intended to suggest or condone bias in any presentation but is made to provide participants with information that might be of potential importance to their evaluation of a presentation. i3 Health does not endorse any products or services.

Relevant financial relationships exist between the following individuals and ineligible companies:

The i3 Health planners, reviewers, and managers have nothing to disclose.

Abby Aliwalas, RPh, ClinPharm, ELS, has no relevant financial relationships to disclose.

Eden E. D. Maack, PhD, has no relevant financial relationships to disclose.

Waqas Haque, MD, MPH, independent clinical content validation reviewer, has no relevant financial relationships to disclose.

i3 Health has mitigated all relevant financial relationships.

INSTRUCTIONS TO RECEIVE CREDIT

In order to receive credit for this activity, participants must read the manuscript and submit a completed evaluation at the end of the activity.

TECHNOLOGY REQUIREMENTS FOR VIRTUAL CME | NCPD | CPE ACTIVITIES

For virtual (asynchronous, archived live, home study; synchronous webinars) CME/NCPD/CPE activities, include access to system requirements:

• The Internet browser(s) supported and minimum versions of each required by the learner to complete the online activity.
• The minimum memory, storage, processor, and Internet speeds require by the learner to complete the online activity.

UNAPPROVED USE DISCLOSURE

i3 Health requires CME/NCPD/CPE faculty (speakers) to disclose to attendees when products or procedures being discussed are off-label, unlabeled, experimental, and/or investigational (not FDA approved), as well as any limitations on the information that is presented, such as data that are preliminary or that represent ongoing research, interim analyses, and/or unsupported opinion. Faculty may discuss information about pharmaceutical agents that is outside of U.S. Food and Drug Administration approved labeling.

This information is intended solely for continuing medical education and is not intended to promote off-label use of these medications. If you have questions, contact the medical affairs department of the manufacturer for the most recent prescribing information.

DISCLAIMER

The information provided at this CME/NCPD/CPE activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

CONTACT INFORMATION

Technical queries or questions regarding activity credit should be directed to i3 Health at support@i3health.com.