Biosimilars in the Evolving Cancer Care Landscape: Experts Address Current Questions, Controversies, and Impact on Clinical Practice
The goal of this activity is to increase participants’ knowledge of and competence in describing the regulatory approval process for biosimilars and effectively using them to replace reference products in the daily practice of treating cancer.
Jointly provided by NCCN and Clinical Care Options, LLC.
This program is intended for medical oncologists and other healthcare professionals, including nurses, nurse practitioners, physician assistants, and pharmacists, who provide medical care for patients with cancer.
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 current and emerging efficacy and safety data for biosimilar agents in the care of patients with cancer.
- Manage patients receiving biosimilars, guided by recent experiences and emerging clinical trial data regarding their safety and efficacy.
- Identify key strategies to counsel and communicate the impact biosimilars may have on a patient’s treatment plan.
Andrew D. Zelenetz, MD, PhD
Medical Director, Quality Informatics
Attending Physician, Lymphoma Service
Department of Medicine
Memorial Sloan Kettering Cancer Center
Professor of Medicine
Weill-Cornell Medical College
New York, New York
Jeffrey Crawford, MD
George Barth Geller Professor of Medicine
Co-Director, Solid Tumor Therapeutics Program
Duke Cancer Institute
Durham, North Carolina
Lee Schwartzberg, MD, FACP
Executive Director, West Cancer Center
Chief, Division of Hematology/Oncology
University of Tennessee Health Science Center
Professor of Medicine, Division of Hematology/Oncology
University of Tennessee Health Science Center
Disclosure of Relevant Financial Relationships
All faculty and activity planners participating in NCCN continuing education activities are expected to disclose any relevant financial relationships with a commercial interest as defined by the ACCME’s, ANCC’s, and ACPE’s Standards for Commercial Support. All faculty presentations have been reviewed for adherence to the ACCME’s Criterion 7: The provider develops activities/educational interventions independent of commercial interests (SCS 1, 2, and 6) by experts on the topics.
The faculty, CCO, and NCCN staff 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 activity.
Jeffrey Crawford, MD, has disclosed that he has received consulting fees from AstraZeneca, Beyond Spring, Celgene, Dova, G1 Therapeutics, Janssen, Merck, Merrimack, Mylan, Pfizer, and Roche and funds for research support (principal investigator) paid to his institution from Amgen, AstraZeneca, Bayer, and Genentech.
Lee S. Schwartzberg, MD, FACP, has disclosed that he has received consulting fees from AbbVie, Amgen, Merck, Pfizer, and Spectrum, and funds for research support from Helsinn and Tesaro.
Andrew D. Zelenetz, MD, PhD, has disclosed that he has received consulting fees from Adaptive Biotechnology, Amgen, BeiGene, Celgene, Genentech/Roche, Gilead, Janssen, and Novartis, and funds for research support from Gilead, MEI Pharma, and Roche.
The activity planning staff listed below have no relevant financial relationships to disclose:
Terrence Fagan; Timothy Quill, PhD; Gordon Kelley; Kevin Obholz, PhD
Kimberly Bayer; Melissa Esplen; Mark A. Geisler; Kristina M. Gregory, RN, MSN, OCN; Kristin Kline Hasson; Rose Joyce; Karen Kanefield; Rashmi Kumar, PhD; Heather Matt; Joan S. McClure, MS; Diane McPherson; Melanie Moletzsky; Lisa Perfidio, MS; Liz Rieder; Shannon Ryan; Kathy Ann Smith, CMP, CHCP; Melinda Somasekhar, PhD (employed by NCCN until October 30, 2017)
The NCCN Activity Planning staff listed below discloses the following relevant financial relationships:
Donald Harting, ELS, CHCP, has disclosed that he has equity interest/stock options from Laboratory Corporation of America (LabCorp).
Katherine Pierce has disclosed that she has equity interest/stock options from Boston Scientific Corporation and Pfizer Inc.
The NCCN clinical information team listed below, who have reviewed content, have no relevant financial relationships to disclose:
Lenora Pluchino, PhD
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. National Comprehensive Cancer Network® (NCCN®) and Clinical Care Options, LLC, 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 NCCN and Clinical Care Options, LLC. Please refer to the official prescribing information for each product for discussion of approved indication, contraindications, and warnings.
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 on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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 National Comprehensive Cancer Network (NCCN) and Clinical Care Options, LLC. NCCN is accredited by the ACCME to provide continuing medical education for physicians.
NCCN 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.
AAPA accepts certificates of participation for educational activities certified for AMA PRA Category 1 Credit™ from organizations accredited by ACCME or a recognized state medical society. PAs may receive a maximum of 1.0 hour of Category 1 credit for completing this activity.
National Comprehensive Cancer Network (NCCN) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
NCCN designates this educational activity for a maximum of 0.88 contact hours.
|National Comprehensive Cancer Network is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.|
NCCN designates this knowledge-based continuing education activity for 1.0 contact hour (0.10 CEUs) of continuing education credit. UAN: 0836-9999-18-032-H01-P
- 1.00 ACPE contact hours
- 1.00 AMA PRA Category 1 Credit™
- 0.88 ANCC contact hours
- 1.00 Participation
To complete this activity, users will need:
- A device with an Internet connection and sound playback capability
- Adobe Reader or other PDF reader software for certificate viewing/printing