The Role of Biosimilars in Cancer Treatment
The development and approval of new biosimilars for cancer treatment will increase in the coming years as patents on originator products expire. Since biosimilars are typically more affordable than originator products, their incorporation into clinical practice represents an opportunity to reduce health care expenditures while ensuring the receipt of high-quality care for patients with cancer. However, challenges remain in the acceptance of biosimilars by physicians, payers and patients in the U.S., similar to those faced by generic drugs when they were first introduced to the market. Increased education and awareness of the FDA-approval process for biosimilars and increased understanding of the evidence required to demonstrate their safety and efficacy will help to close this practice gap and ensure the acceptance and use of biosimilars in clinical practice. Healthcare providers should also be made aware of specific issues concerning the care of patients receiving biosimilars, including the need for careful monitoring to identify adverse events and implementation of appropriate supportive care measures applicable to the originator product.
This educational program is designed to meet the educational needs of physicians, nurses, physician assistants, pharmacists, and other health care professionals who manage patients with cancer.
Following this program, participants should be able to:
- List the key parameters required to demonstrate biosimilarity and the rationale for extrapolation
- Identify biosimilar MABs that are FDA-approved and outline the current strategies for their use in cancer treatment
- Discuss the potential challenges for the incorporation of biosimilars in oncology care
Andrew D. Zelenetz, MD, PhD
Memorial Sloan Kettering Cancer Center
NCCN Medical Education Disclosure Policy
It is the policy of NCCN that every 12 months, all faculty, moderators, activity planners and all internal planning staff participating in NCCN continuing education activities are expected to disclose any financial relationships with a commercial interest as defined by the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support. In addition, all faculty presentations have been reviewed for adherence to the ACCME’s Standards for Commercial Support (the provider develops activities/educational interventions independent of commercial interests [SCS 1, 2 and 6] by experts on the topics).
Per the ACCME Standards for Commercial Support, individuals who do not disclose relevant financial relationships will be disqualified from involvement in the CE activity as a content developer, planner, or presenter. A complete list of individuals’ relationships with external entities is available upon request.
NCCN continuing education considers financial relationships to create a “conflict of interest” when an individual has both a financial relationship with a commercial interest and the opportunity to affect CE content about the products or services of a commercial interest with which he/she and/or a spouse or partner has a financial relationship.
NCCN continuing education considers “relevant financial relationships” as financial relationships in any amount occurring within the past 12 months that create a conflict of interest. NCCN does not set a minimal dollar amount for relationships to be significant. Inherent in any amount is the incentive to maintain or increase the value of the relationship.
All faculty for this continuing education activity are competent in the subject matter and qualified by experience, training, and/or preparation for the tasks and methods of delivery.
Faculty presentations may include discussion of off-label use.
Faculty will disclose that the use in question is not currently approved by the FDA per the product labeling.
The faculty listed below discloses the following relevant financial relationships:
Andrew D. Zelenetz, MD, PhD
AbbVie, Inc.: Scientific Advisor
Adaptive Biotechnologies Corporation: Consulting Fees
Amgen, Inc.: Consulting Fees
AstraZeneca Pharmaceuticals LP: Scientific Advisor
BeiGene: Grant/Research Support; Other financial benefit
Celgene Corporation: Consulting Fees
Genentech, Inc.: Scientific Advisor
Genentech, Inc. / Roche Laboratories, Inc.: Consulting Fees
Gilead Sciences, Inc.: Consulting Fees; Grant/Research Support; Scientific Advisor
Janssen Pharmaceuticals Products, LP: Consulting Fees
MEI Pharma.: Grant/Research Support
MorphoSys AG: Scientific Advisor
Novartis Pharmaceuticals Corporation: Consulting Fees
Pharmacyclics: Scientific Advisor
Roche Laboratories, Inc.: Scientific Advisor
Verastem Oncology: Consulting Fees
NCCN Staff Disclosures
The NCCN Activity Planning staff listed below discloses no relevant financial relationships:
Robert W. Carlson, MD; Melissa Esplen; Mark A. Geisler; Kristina M. Gregory, RN, MSN, OCN; Kristin Kline Hasson; Rose Joyce; Karen Kanefield; Wui-Jin Koh, MD; Lisa Perfidio, MS; Kathy Ann Smith, CHCP; Sarah Weinstein; Gary J. Weyhmuller, MBA, SPHR
The NCCN Clinical staff listed below below discloses no relevant financial relationships:
Mary Anne Bergman; Jennifer L. Burns, BS; Susan D. Darlow, PhD; Mary A. Dwyer, MS, CGC; Anita M. Engh, PhD; Ellen Erkess; Deborah A. Freedman-Cass, PhD; Lisa Gurski, PhD; Miranda Hughes, PhD; Alyse Johnson-Chilla; Rashmi Kumar, PhD; Nicole R. McMillian, MS, CHES; Ndiya Ogba, PhD; Lenora Pluchino, PhD; Jillian Scavone, PhD; Dorothy A. Shead, MS; Hema Sundar, PhD
The NCCN Clinical staff listed below below discloses the following relevant financial relationships:
Griselda Zuccarino-Catania, PhD
Janssen Pharmaceutical Products, LP: Salary*
In support of improving patient care, National Comprehensive Cancer Network (NCCN) 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.
NCCN designates this enduring material for a maximum of 0.75 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
NCCN designates this educational activity for a maximum of 0.75 contact hour.
NCCN designates this knowledge-based continuing education activity for 0.75 contact hour (0.075CEUs) of continuing education credit. UAN: JA4008196-0000-20-050-H01-P
NCCN 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 0.75 AAPA Category 1 CME credits. Approval is valid until 3/1/2021. PAs should only claim credit commensurate with the extent of their participation.
- 0.75 AAPA Category 1 CME credit
- 0.75 ACPE contact hours
- 0.75 AMA PRA Category 1 Credit™
- 0.75 ANCC contact hours
- 0.75 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