The Era of Therapeutic Biosimilars Has Arrived: What You Need to Know
The introduction of biosimilar mAbs into the oncology treatment landscape has the potential to provide substantial cost savings without compromising treatment efficacy. However, unlike the generic small molecule drugs, biosimilars will not be identical to the reference biological product due to the complexities and proprietary nature of their manufacturing processes and some level of heterogeneity will exist between the biosimilar and the reference biological product. A thorough knowledge of the FDA-approval process for biosimilars (including the strict efficacy and safety requirements set by the FDA) is essential for clinicians to make informed decisions and integrate biosimilars into clinical practice in the appropriate patient population. Health care professionals (clinicians, pharmacists and nurse practitioners) should also be aware of the biosimilar nomenclature to avoid any confusion between reference biological product and the approved biosimilar. The use of therapeutic biosimilars should also involve careful patient monitoring to identify the adverse effects and implementation of supportive care measures that are applicable to the reference biological product. Increased education for all health care professionals and patients will be helpful to close the practice gap and for the successful utilization of biosimilars in clinical practice.
This information was originally presented at the NCCN 2019 Annual Congress: Hematologic Malignancies™ held in San Francisco, CA, on September 27-28, 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:
- Describe the regulatory process for the evaluation and approval of biosimilar mAbs and the rationale for extrapolation across other indications.
- Identify the biosimilar mAbs that are FDA-approved and the indications for their clinical use.
- Review the efficacy and safety data from the comparative clinical trials that have evaluated biosimilar mAbs and their reference biological products to inform decision making.
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.: Consulting Fee; Scientific Advisor
Adaptive Biotechnologies Corporation: Consulting Fee
Amgen Inc.: Consulting Fee
AstraZeneca Pharmaceuticals LP: Consulting Fee; Scientific Advisor
BeiGene: Grant/Research Support; Other Financial Benefit
Celgene Corporation: Consulting Fee
Genentech, Inc./Roche Laboratories, Inc.: Consulting Fee
Gilead Sciences, Inc.: Consulting Fee; Grant/Research Support
Janssen Pharmaceutica Products, LP: Consulting Fee
MEI Pharma Inc.: Grant/Research Support
MorphoSys AG: Scientific Advisor
Novartis Pharmaceuticals Corporation: Consulting Fee
Pharmacyclics: Consulting Fee
Roche Laboratories, Inc.: Grant/Research Support
NCCN Staff Disclosures
The NCCN Activity Planning staff listed below discloses no relevant financial relationships:
Melissa Esplen; Mark A. Geisler; Kristina M. Gregory, RN, MSN, OCN; Kristin Kline Hasson; Rose Joyce; Karen Kanefield; Lisa Perfidio, MS; Shannon Ryan, CMP; Sarah Sinclair; Kathy Ann Smith, CHCP
The NCCN Leadership listed below discloses no relevant financial relationships:
Robert W. Carlson, MD; Wui-Jin Koh, MD; Gary J. Weyhmuller, MBA, SPHR
The NCCN Clinical staff listed below discloses no relevant financial relationships:
Mary A. Dwyer, MS, CGC; Hema Sundar, PhD
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 activity for a maximum of .5 AMA PRA Category 1 Credits™. 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 .5 contact hours.
NCCN designates this knowledge-based continuing education activity for .5 contact hours (0.05 CEUs) of continuing education credit. UAN: JA4008196-0000-19-098-H01-P
NCCN has been authorized by the American Academy of PAs (AAPA) to award AAPA Catergory 1 CME credit for activities planned in accordance with AAPA CME criteria. This activity is designated for .5 AAPA Catergory 1 CME credits. Approval is valid until October 31, 2020. PAs should only claim credit commensurate with the extent of their participation.
- 0.50 AAPA Category 1 CME credit
- 0.50 ACPE contact hours
- 0.50 AMA PRA Category 1 Credit™
- 0.50 ANCC contact hours
- 0.50 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