New Biosimilar Approvals for Myeloid Growth Factors and Anemia
Challenges remain in the acceptance of biosimilar medications by physicians, payers, and patients in the U.S., similar to the challenges faced by generic drugs when they were first introduced to the market. Increased education and awareness of the FDA-approval process for biosimilars as well as increased understanding of their safety and efficacy will help to close this practice gap and ensure the acceptance and use of biosimilars in clinical practice. The development of new biosimilars will increase in the coming years as patents on originator products begin to expire, representing an opportunity to reduce health care expenditures while ensuring the receipt of high-quality care for patients living with cancer.
This information was originally presented at the NCCN 2019 Annual Conference: Improving the Quality, Effectiveness, and Efficiency of Cancer Care™ held in Orlando, Florida, March 21-23, 2019.
This educational program is designed to meet the educational needs of the interprofessional oncology care team, including: physicians/oncologists, nurses, physician assistants, pharmacists, and other healthcare professionals who manage patients with cancer.
Following this program, participants should be able to:
- List the key parameters used to designate a biological product as a biosimilar.
- Outline the current strategies for the use of biosimilar epoetin alfa-epbx for the treatment of cancer-induced anemia.
- Identify the potential challenges for the use of biosimilars in oncology care.
Gary H. Lyman, MD, MPH
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance
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:
Gary H. Lyman, MD, MPH
Agendia BV: Consulting Fee
Amgen Inc.: Consulting Fee
Genomic Health, Inc.: Consulting Fee
Halozyme, Inc.: Consulting Fee
Mylan: Consulting Fee
Partners Healthcare: Consulting Fee
Pfizer Inc.: Consulting Fee
Samsung Bioepis: Consulting Fee
Spectrum Pharmaceuticals, Inc.: Consulting Fee
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; Lisa G. Kimbro, MBA, CPA (Employed by NCCN until 8/10/18); Wui-Jin Koh, MD; Joan S. McClure, MS (Employed by NCCN until 8/1/18); Lisa Perfidio, MS; Sarah Sinclair; Kathy Ann Smith, CHCP; Gary J. Weyhmuller, MBA, SPHR
The NCCN Clinical staff listed below discloses no relevant financial relationships:
Lenora Pluchino, PhD; Jennifer L. Burns, BS
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 0.65 contact hour.
NCCN designates this knowledge-based continuing education activity for 0.75 contact hour (0.075 CEUs) of continuing education credit. UAN: JA4008196-0000-19-050-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 credit. Approval is valid until March 1, 2020. 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™
- 0.65 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