Integrating Oncology Treatment Biosimilars Into Clinical Practice
  • CME
  • CE

Learn about the integration of biosimilars into oncology care with this expert-authored module reviewing biosimilar fundamentals, the regulatory review process for biosimilars, current FDA-approved biosimilars, and key trial data on biosimilars in breast and lung cancers.
Gary H. Lyman, MD, MPH, FASCO, FACP, FRCP
Physicians: maximum of 1.0 AMA PRA Category 1 Credit
Registered Nurses: 1.0 Nursing contact hour
Pharmacists: 1.0 contact hour (0.1 CEUs)
Released: April 20, 2020 Expiration: April 19, 2021

Learning Objectives

Upon completion of this activity, participants should be able to:
  • Describe differences between biosimilars and reference biologics in terms of their structure, function, regulatory requirements, and data demonstrating biosimilarity
  • Discuss key clinical considerations associated with the use of biosimilars in the treatment of cancer, including extrapolation, immunogenicity, pharmacovigilance, and patient communication
  • Consider optimal integration of biosimilars into practice to maximize clinical outcomes in patients with cancer
  • Counsel patients and members of the healthcare team about the available safety and efficacy data for biosimilars and reference biologics and the potential impact of interchangeability and substitution on dose/response, adverse events, and clinical outcomes

Acknowledgements

Provided by Clinical Care Options, LLC

Clinical Care Options, LLC
12001 Sunrise Valley Drive
Suite 300
Reston, VA

Sophia Kelley
(203)-316-2125
skelley@clinicaloptions.com
www.clinicaloptions.com

Supported by an educational grant from
Amgen

Information on this Educational Activity

Clinical Care Options, LLC (CCO) requires instructors, planners, managers, and other individuals who are in a position to control the content of this activity to disclose any relevant conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to CCO policy. CCO is committed to providing its learners with high-quality CME/CE activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME/CE activity:

Faculty

Gary H. Lyman, MD, MPH, FASCO, FACP, FRCP

Senior Lead, Healthcare Quality and Policy
Hutchinson Institute for Cancer Outcomes Research
Fred Hutchinson Cancer Research Center
Professor of Medicine
University of Washington School of Medicine
Seattle, Washington

Gary H. Lyman MD, MPH, FASCO, FACP, FRCP, has disclosed that he has received fees for consulting from Mylan, Samsung, and Sandoz.

Staff

Jill Sakai, PhD

Editorial Contributor

Jill Sakai, PhD, has no relevant conflicts of interest to report.
Kiran D. Mir-Hudgeons, PhD

Manager, Editorial Operations

Kiran Mir-Hudgeons, PhD, has no relevant conflicts of interest to report.
Megan Cartwright, PhD

Senior Clinical Editor

Megan Cartwright, PhD, has no relevant conflicts of interest to report.
Terrence Fagan

Associate Scientific Director

Terrence Fagan has no relevant conflicts of interest to report.
Timothy A. Quill, PhD

Associate Director, Scientific Services

Timothy Quill, PhD, has no relevant conflicts of interest to report.
Kevin Obholz, PhD

Senior Director, Educational Strategy

Kevin Obholz, PhD, has no relevant conflicts of interest to report.
Jim Mortimer

Senior Director, Oncology Programs and Partnership Development

Jim Mortimer reports that his spouse has ownership interest in AstraZeneca.
Jason Everly, PharmD

Director, Program Development and Educational Impact

Jason J. Everly, PharmD, BCOP, CHCP, has no relevant conflicts of interest to report.
Elaine S. DeMeyer, MSN, RN, AOCN

Editorial Contributor

Elaine S. DeMeyer, MSN, RN, AOCN, has no relevant conflicts of interest to report.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Target Audience

This program is intended for physicians, nurses, pharmacists, and other healthcare clinicians who care for patients with cancer who are candidates for biosimilar agents.

Goal

The goal of this activity is to improve participants’ competence in applying the latest practice-changing data in the individualized clinical management of patients with cancer who are candidates for treatment with biologic agents.

Accreditation

Joint Accreditation Statement

In support of improving patient care, Clinical Care Options, LLC (CCO) 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.

Physician Continuing Medical Education

Credit Designation

CCO designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nursing Continuing Education

Credit Designation

The maximum number of hours awarded for this Continuing Nursing Education activity is 1.0 contact hour.

Pharmacist Continuing Education

Credit Designation

CCO designates this continuing education activity for 1.0 contact hour (0.1 CEUs) of the Accreditation Council for Pharmacy Education. Universal Activity Number - JA4008176-0000-20-050-H01-P.

Type of Activity: Application

Upon successfully completing the post-test with a score of 65% or better and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 60 days.

Program Medium

This program has been made available online.

Instructions for Credit

Participation in this self-study activity should be completed in approximately 1.0 hours. To successfully complete this activity and receive credit, participants must follow these steps during the period from April 20, 2020, through April 19, 2021:

1. Register online at http://www.clinicaloptions.com.
2. Read the target audience, learning objectives, and faculty disclosures.
3. Study the educational activity online or printed out.
4. Submit answers to the posttest questions and evaluation questions online.

You must receive a test score of at least 65% and respond to all evaluation questions to receive a certificate. After submitting the evaluation, you may access your online certificate by selecting the certificate link on the posttest confirmation page. Records of all CME/CE activities completed can be found on the "CME/CE Manager" page. There are no costs/fees for this activity.

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