Preparing the Oncology Practice for the Biosimilars Revolution
This CE/CME/CEU-accredited supplement is jointly provided by
Release date: September 15, 2017
Expiration date: September 15, 2018
Annenberg Center for Health Sciences at Eisenhower
39000 Bob Hope Drive, Dinah Shore Bldg. Rancho Mirage, CA 92270
Estimated time to complete activity: 1.0 hours
Journal of Oncology Practice
94 North Woodhull Road
Huntington, NY 11743
This activity is supported by educational grants from Amgen and Apobiologix.
Gary H. Lyman, MD, MPH, Co-Director, Hutchinson Institute for Cancer Outcomes Research, Public Health Sciences Division and Clinical Research Divisions, Fred Hutchinson Cancer Research Center; Professor of Medicine, University of Washington School of Medicine, Seattle, Washington
R. Donald Harvey, PharmD, BCOP, Associate Professor, Departments of Hematology and Medical Oncology and Pharmacology, Emory School of Medicine; Director, Phase I Clinical Trials Section, Winship Cancer Institute, Atlanta, Georgia
Robert M. Rifkin, MD, Medical Director, Biosimilars, The US Oncology Network/McKesson Specialty Health, The Woodlands, Texas
Susan R. Peck, PhD, McKesson Specialty Health, The Woodlands, Texas
Steven J. Lemery, MD, MHS, Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland
Håkan Mellstedt, MD, PhD, Professor, Department of Oncology-Pathology, Karolinska Institute, Solna, Stockholm, Sweden
Rena Conti, PhD, Associate Professor, Department of Pediatrics, Section of Hematology/Oncology; Department of Public Health Sciences, The University of Chicago, Chicago, Illinois
Activity Rationale and Purpose
Biosimilars are a novel class of biologic products that have been approved based on the basis of their being highly similar to an already approved biologic, with no clinically meaningful differences in terms of safety and effectiveness from the reference product. It is anticipated that many oncology biosimilars will be approved by the U.S. Food and Drug Administration within the next 18-24 months, following patent expiration of the original products. This supplement to the Journal of Oncology Practice will provide oncologists and other oncology professionals with the most up-to-date information on the chemical nature of biosimilars, their manufacturing process, how they may differ from reference products and generics, and any issues that may arise from their use in oncology practice.
The target audience for this educational activity includes oncologists, oncology practice managers, doctors of nursing practice, nurse practitioners, physician assistants, oncology clinical pharmacists, oncology advanced practice nurses, and other health-care professionals involved in oncology care delivery.
After completing this educational activity, participants should be able to:
- Demonstrate a clear understanding of the chemical nature of biosimilars and their differences from biologics and generics.
- Identify biosimilars with recent or pending FDA approvals, and recommendations for their clinical use.
- Be aware of biosimilar nomenclature to avoid any confusion between prescribed drug and parent biologic or other biosimilars.
- Record any unique toxicities associated with specific biosimilars in patients’ charts to clearly indicate the exact version of the biosimilar being used.
Statement of Credit—Participants who successfully complete this activity (including the submission of the posttest and evaluation form) will receive a statement of credit.
Physicians. 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 Annenberg Center for Health Sciences at Eisenhower and Harborside Medical Education. The Annenberg Center is accredited by the ACCME to provide continuing medical education for physicians.
The Annenberg Center for Health Sciences at Eisenhower designates this enduring activity for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Nurses. Annenberg Center for Health Sciences is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
A maximum of 1.0 contact hour may be earned for successful completion of this activity.
Provider approved by the California Board of Registered Nursing, Provider No. 13664, for 1.0 contact hour.
Pharmacists. The Annenberg Center for Health Sciences at Eisenhower is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This program has been assigned ACPE Universal Program #0797-9999-17-068-H01-P. This program is designated for up to 1.0 contact hour (0.1 CEUs) of continuing pharmacy education credit.
All individuals in positions to control the content of this program (eg, planners, faculty, content reviewers) are expected to disclose all financial relationships with commercial interests that may have a direct bearing on the subject matter of this continuing education activity. The Annenberg Center for Health Sciences at Eisenhower has identified and resolved all conflicts of interest in accordance with the Annenberg Center for Health Sciences at Eisenhower policies and procedures. Participants have the responsibility to assess the impact (if any) of the disclosed information on the educational value of the activity.
Gary H. Lyman, MD, MPH, is a consultant/advisory board member for Halozyme, G1 Therapeutics, and Coherus Biosciences, and has received institutional research funding from Amgen.
R. Donald Harvey, PharmD, BCOP, has received institutional research funding from Novartis, AstraZeneca, Agensys, Merck, Bristol-Myers Squibb, and Amgen.
Robert M. Rifkin, MD, is an employee of McKesson Specialty Health; has reported stock ownership in McKesson; and is a consultant/advisory board member for Takeda, Celgene, Amgen, EMD Serono, Boehringer Ingelheim, and Sandoz.
Susan R. Peck, PhD, is an employee of McKesson Specialty Health.
Steven J. Lemery, MD, MHS, has no relationships to disclose.
Håkan Mellstedt, MD, PhD, has received honoraria from Sandoz, Amgen, Pfizer, Roche, Boehringer Ingelheim, and Hospira; is a consultant/advisory board member for Sandoz, Amgen, Pfizer, Roche, Boehringer Ingelheim, and Hospira; and has participated in a speakers’ bureau for Global Academy for Health Sciences.
Rena Conti, PhD, has no relationships to disclose.
ANNENBERG CENTER FOR HEALTH SCIENCES AT EISENHOWER
John Bayliss, VP, Business Development at the Annenberg Center for Health Sciences at Eisenhower, spouse is an employee of Amgen, Inc; all other staff at the Annenberg Center for Health Sciences at Eisenhower have no relevant commercial relationships to disclose.
Moshe Ornstein, MD, MA, Cleveland Clinic Taussig Cancer Center, has no potential conflicts of interest to disclose.
Dorothy Caputo, MA, BSN, RN, EduPro Resources, LLC, has no potential conflicts of interest to disclose.
Harborside Press and Harborside Medical Education staff have no potential conflicts of interest to disclose.
This activity has been designed to provide continuing education that is focused on specific objectives. In selecting educational activities, clinicians should pay special attention to the relevance of those objectives and the application to their particular needs. The intent of all Annenberg Center for Health Sciences at Eisenhower educational opportunities is to provide learning that will improve patient care. Clinicians are encouraged to reflect on this activity and its applicability to their own patient population.
The opinions expressed in this activity are those of the faculty and reviewers and do not represent an endorsement by Annenberg Center for Health Sciences at Eisenhower of any specific therapeutics or approaches to diagnosis or patient management.
This educational activity may contain discussion of published as well as investigational uses of agents that are not approved by the U.S. Food and Drug Administration. For additional information about approved uses, including approved indications, contraindications, and warnings, please refer to the prescribing information for each product.
How to Earn Credit
To access the learning assessment and evaluation form online, visit https://education.annenberg.net/jop-biosimilars
Statement of Credit: Participants who successfully complete this activity (including scoring of a minimum of 70% on the learning assessment) and complete and submit the evaluation
- 1.00 ACPE
- 1.00 AMA PRA Category 1 Credit(s)™
- 1.00 Attendance
- 1.00 CA-BRN
- 1.00 ANCC