Understanding the Expanding Role of Biosimilars in Quality Cancer Care
The goal of this activity is to increase participants’ 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 National Comprehensive Cancer Network® (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 potential differences between biosimilars and reference biologics in terms of their structure, function, regulatory requirements for approval, and data required to demonstrate biosimilarity, and the potential to increase access to biologic medications for cancer patients
- Discuss key clinical considerations associated with the use of biosimilars in oncology, including extrapolation, immunogenicity, pharmacovigilance, and patient communication
- Evaluate recent experiences and emerging clinical trial data regarding the safety and efficacy of biosimilars for supportive and therapeutic cancer care to aid informed decision making of safe integration into clinical practice
- Identify benefits and address key misconceptions/myths that have arisen around biosimilar development and use in oncology practice
Gary H. Lyman, MD, MPH, FASCO, FRCP (Edin)
Jeffrey Crawford, MD
Rowena Schwartz, PharmD, BCOP
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, NCCN staff, and CCO 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.
Gary Lyman, MD, MPH, FASCO, FRCP (Edin), has disclosed that he has received funds for research support (principal investigator) paid to his institution from Amgen.
Jeffrey Crawford, MD, has disclosed that he has received consulting fees from Merck, Novartis, and Pfizer; fees for non-CME services from Beyond Spring, Celgene, G1 Therapeutics, Janssen, Merrimack, and Roche; and funds for research support (principal investigator) paid to his institution from Amgen, AstraZeneca, and Bayer.
Rowena Schwartz, PharmD, BCOP, has disclosed that she has received salary from McKesson (employment ended August 2016) and owns stock in McKesson.
The activity planning staff listed below has no relevant financial relationships to disclose:
NCCN: Kristina M. Gregory, RN, MSN, OCN; Karen Kanefield; Kristin Kline Hasson; Joan S. McClure, MS; Lisa Perfidio; Kathy Smith
CCO: Terrence Fagan; Rachael Andrie, PhD; Zachary Schwartz, MSc, ELS; and Kevin Obholz, PhD, have no real or apparent conflicts of interest to report.
The NCCN clinical information team listed below, who have reviewed content, have no relevant financial relationships to disclose: Lisa Gurski, PhD; Rashmi Kumar, 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 NCCN and Clinical Care Options, LLC. NCCN is accredited by the ACCME to provide continuing medical education for physicians.
NCCN designates this enduring activity for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the 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 1.4 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 1.5 contact hours (0.15 CEUs) of continuing education credit. UAN: 0836-9999-17-077-H01-P
- 1.50 ACPE contact hours
- 1.50 AMA PRA Category 1 Credit™
- 1.40 ANCC contact hours
- 1.50 Participation
To complete this activity, users will need:
- A device with an Internet connection
- One of the two latest versions of Google Chrome, Mozilla Firefox, or Safari (Internet Explorer is no longer supported)
- Adobe Flash Player and/or an HTML5 capable browser for video or audio playback
- Adobe Reader or other PDF reader software for certificate viewing/printing