Axel Grothey, MD
Director, GI Cancer Research
West Cancer Center and Research Institute
Provided by North American Center for Continuing Medical Education, LLC (NACCME), an HMP Company.
For questions regarding this educational activity, please call 609-371-1137 or email email@example.com.
This educational activity is designed to meet the educational needs of those who are involved and/or interested in the treatment of patients with GI cancers, community oncologists, physicians, physician assistants, physicians-in-training, oncology nurses, and pharmacists.
Biologics have become an essential element in cancer treatment and supportive care. The use of biologics has grown exponentially since their emergence. Although biologics have effectively transformed cancer treatment, they are very expensive to manufacture, as they are derived from living organisms and therefore are highly complex and impossible to replicate using inorganic methods. Efforts are widely underway to help control these rising costs in cancer treatment and drive down related expenditures. To that effect, biosimilar products have been developed that are highly similar to the reference biologic, with no clinically significant differences in terms of safety, purity, and potency. To date, 23 US licensed biosimilars have gained approval, most within the last 2 years, and many more are under clinical review or in late-stage development. The availability of biosimilars confers a number of benefits to the patient, provider, and health care system. FDA-approved biosimilars have demonstrated similar efficacy and safety to the originator biologics in clinical trials (alone and in combination), and they have the potential to dramatically reduce health care costs while maintaining quality and health outcomes.
This webcast aims to provide a rationale for the incorporation of biosimilars into management strategies for CRC, with a focus on explaining many aspects of biosimilars that may not be evident to all clinicians.
After participating in this activity, learners should be better able to:
- Summarize the potential benefits of incorporating biosimilars into clinical practice for treatment of patients with CRC
- Outline the FDA totality of evidence process by which biosimilar medications are evaluated
- Describe the justification for the extrapolation of efficacy and safety data from one indication to another, specifically in regard to biosimilars approved for treatment of metastatic CRC
- Employ shared–decision-making strategies to address patient barriers to biosimilar use in clinical practice
To be eligible for credit, participants must complete the online activity and the evaluation. Upon completing the activity, there will be instructions on how to complete the evaluation and print a certificate or other documentation of credit.
Release Date: November 20, 2020
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Estimated Time to Complete: 60 minutes
There is no fee associated with this activity.
Supported by an educational grant from Pfizer, Inc.
In support of improving patient care, NACCME 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.
NACCME designates this internet live/enduring activity for a maximum of 1.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
This continuing nursing education activity awards 1.00 contact hours.
Provider approved by the California Board of Registered Nursing, Provider #13255 for 1.00 contact hours.
This internet live/enduring, knowledge-based activity (Universal Activity Number:JA0006201-0000-20-216-H01-P) has been approved for a maximum of 1.00 contact hours (.100 CEUs).
The certificate is not the official record of your participation in the activity. The official record of credit will be the information in CPE Monitor system. Following ACPE Policy, NACCME will not be able to report your claimed credit to CPE Monitor after this 60-day period. Eligibility for pharmacy credit is contingent upon the successful completion of a post-test and/or evaluation for each activity or session attended.
NACCME has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with the AAPA CME Criteria. This activity is designated for 1.00 AAPA Category 1 credit(s). PAs should only claim credit commensurate with the extent of their participation.
This continuing medical education activity may include device or medicine brand names for participant clarity purposes only, due to the presence of different branded versions of the same product. No product promotion or recommendation should be inferred.
This activity may contain information about experimental and other uses of drugs or devices that are not currently approved by the European Medicines Agency (EMA) of the European Union or the Food and Drug Administration (FDA) of the United States. Participants are strongly encouraged to consult approved product labeling for any drug or device mentioned in this activity before use. The opinions expressed during this activity are the opinions of the respective authors, presenters or moderators and do not necessarily reflect the opinions of NACCME.
The material presented and related discussions are not intended to be medical advice, and the presentation or discussion of such material is not intended to create and does not establish a physician-patient relationship. Medical advice of any nature should be sought from an individual’s own physician.
Neither NACCME nor any of its subsidiaries or affiliates is affiliated with, or formally endorsed by a medical society.
The opinions expressed in this educational activity are those of the faculty and are not attributable to NACCME or HMP. Clinical judgment must guide each professional in weighing the benefits of treatment against the risk of toxicity. Dosages, indications, and methods of use for products referred to in this activity are not necessarily the same as indicated in the package insert for each product, may reflect the clinical experience of the presenters, and may be derived from the professional literature or other clinical sources. Consult complete prescribing information before administering.
NACCME, LLC is an independent provider(s) of continuing medical education. NACCME, LLC has no proprietary or financial interest in medical or healthcare products over which the FDA (USA) or EMA (EU) has regulatory authority.
NACCME, LLC assures that all educational materials are reviewed to ensure for the absence of commercial bias, fair balance, scientific objectivity, and levels of evidence. The educational activity will not be influenced by commercial organizations and will not conflict with any other scheduled educational activities.
According to the disclosure policy of NACCME, faculty, editors, managers, and other individuals who are in a position to control content are required to disclose any relevant financial relationships with relevant commercial companies related to this activity. All relevant conflicts of interest that are identified are reviewed for potential conflicts of interest. If a conflict is identified, it is the responsibility of NACCME to initiate a mechanism to resolve the conflict. The existence of these interests or relationships is not viewed as implying bias or decreasing the value of the presentation.
In addition to the faculty listed below, NACCME planners and staff include Christopher Bolwell, Samantha Conforti, Mary Johnson, Amanda Mulder, Randy Robbin, Manjusha Sala, Greaton Sellers, and Shannon Stevenson.
Christopher Bolwell is a shareholder of GlaxoSmithKline. GlaxoSmithKline is not supporting this activity, nor does any content relate to their products or services.
No other planner has disclosed a relevant financial relationship with any commercial interest.
The faculty has reported the following:
Axel Grothey, MD: Consultant-Amgen, Array/Pfizer, Bayer Germany, Caris, Genentech/Roche; Grant/Research Support-Array/Pfizer, Bayer Germany, Caris, Merck, Natera, OBI Pharma
North American Center for Continuing Medical Education (NACCME) complies with the legal requirements of the Americans with Disabilities Act and the rules and regulations thereof. If any participant in this educational activity is in need of accommodations, please call 609-371-1137.
NACCME protects the privacy of personal and other information regarding participants, educational partners, and joint providers. NACCME and our joint providers will not release personally identifiable information to a third party without the individual’s consent, except such information as is required for reporting purposes to the appropriate accrediting agency. NACCME maintains physical, electronic, and procedural safeguards that comply with federal regulations to guard your nonpublic personal information.
Copyright © 2020 by North American Center for Continuing Medical Education, LLC. All rights reserved. No part of this accredited continuing education activity may be reproduced or transmitted in any form or by any means, electronic or mechanical, without first obtaining permission from North American Center for Continuing Medical Education.
Any participant wanting to file a grievance with respect to any aspect of a continuing education activity accredited by NACCME, LLC may contact Samantha Conforti, Manager, Accreditation and Compliance, by phone at 609-371-1137, by email at firstname.lastname@example.org or in writing at 104 Windsor Center Drive, East Windsor, NJ 08520. The Manager, Accreditation and Compliance will review the grievance and respond within 30 days of receiving the complaint. If the participant is unsatisfied with the response, an appeal to the Senior Manager/Director or the Executive Vice President, Chris Bolwell, Accreditation and Compliance, can be requested for a second level of review. Mr. Bolwell can be contacted via phone at 678-242-0801, by email at email@example.com or in writing at 11675 Rainwater Drive, Suite 600 Alpharetta, GA 30009.