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The Rapidly Evolving Role of Biosimilars: Educating Specialists and Facilitating Shared Decision Making With Patients
E-Publication E-Publication

The Rapidly Evolving Role of Biosimilars: Educating Specialists and Facilitating Shared Decision Making With Patients


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E-Publication E-Publication
By clicking "Continue," you are confirming that you have reviewed the CME information and read, understood, and unconditionally agreed to the Privacy Notice and Terms of Use.


Maximum Credits:
E-Publication E-Publication
By clicking "Continue," you are confirming that you have reviewed the CME information and read, understood, and unconditionally agreed to the Privacy Notice and Terms of Use.


Maximum Credits:

Overview: This accredited CME publication describes biosimilars and how they compare with their originator products, reviews FDA guidance on the biosimilar approval process, and discusses key issues for prescribers. In addition, brief clinical case vignettes present examples of how biosimilars may appear in practice.

CME Information:

Sanjiv S. Agarwala, MD
Professor and Chief
Hematology & Oncology
St. Luke’s Cancer Center
Temple University
Philadelphia, PA

Gary R. Lichtenstein, MD
Professor of Medicine
Raymond and Ruth Perelman School of Medicine of the University of Pennsylvania
Director, Center for Inflammatory Bowel Disease
Department of Medicine
Division of Gastroenterology
Perelman Center for Advanced Medicine
Philadelphia, PA

William F. C. Rigby, MD
Professor of Medicine, Microbiology, and Immunology
Director of Rheumatology Research
The Geisel School of Medicine at Dartmouth
Lebanon, NH

Activity Planners
Christie Avraamides, PhD
Clinical Content Manager
Baltimore, MD

Rebecca L. Julian, MS, ELS
Senior Manager, Editorial
Baltimore, MD

Samantha Gordon
CME Specialist
Baltimore, MD

Kathryn Schaefer, MSN, RN
Lead Nurse Planner
Lansing, MI
Lori K. Pender, PharmD, MPH, BCOP, ELS
Seattle, WA
Learning Objectives
Upon completion, participants should be able to:

  • Describe how the structural and clinical properties of biosimilars relate to their reference products
  • Identify criteria used in the regulatory process governing the approval of biosimilars across indications in the United States
  • Apply available evidence, current policy guidance, and cost considerations to decisions about prescribing and monitoring treatment with biosimilars

Target Audience
This activity is intended for gastroenterology, rheumatology, and hematology/oncology physicians, physician assistants, and nurse practitioners.
Series Overview/Statement of Need
Biologics have transformed the treatment of cancer, rheumatoid arthritis, and inflammatory bowel disease; however, they are an expensive treatment option. Indeed, biologic therapies account for 28% of prescription drug spending, even though they account for fewer than 1% of all prescriptions dispensed. With several biologics having lost patent protection and many more patents expiring by 2020, a market for lower-priced alternatives to these branded products is growing. As a result, clinicians need to understand what biosimilars are, how they are manufactured, and how they compare with their originator products. Furthermore, understanding the regulatory process that these biosimilars undergo will help clinicians make informed decisions about using biosimilars in their practice.
Providership Statement
Provided by Med-IQ.

Accreditation/Designation Statements
Med-IQ is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Med-IQ 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.
Nurse practitioners, physician assistants, and other healthcare professionals who successfully complete the activity will receive a Statement of Participation indicating the maximum credits available.
Medium/Method of Participation
This CME activity consists of a 0.75-credit online publication. To receive credit, read the introductory CME material, read the publication, and complete the post-survey, evaluation, attestation, and post-test, answering at least 70% of the post-test questions correctly.

Initial Release Date: December 15, 2017
Expiration Date: December 14, 2018
Estimated Time to Complete This Activity: 45 minutes

Disclosure Policy
Med-IQ requires any person in a position to control the content of an educational activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines “relevant financial relationships” as those in any amount occurring within the past 12 months, including those of a spouse/life partner, that could create a conflict of interest (COI). Individuals who refuse to disclose will not be permitted to contribute to this CME activity in any way. Med-IQ has policies in place that will identify and resolve COIs prior to this educational activity. Med-IQ also requires faculty to disclose discussions of investigational products or unlabeled/unapproved uses of drugs or devices regulated by the US Food and Drug Administration.
Disclosure Statement
The content of this activity has been peer reviewed and has been approved for compliance. The faculty and contributors have indicated the following financial relationships, which have been resolved through an established COI resolution process, and have stated that these reported relationships will not have any impact on their ability to give an unbiased presentation.
Sanjiv S. Agarwala, MD, has indicated no real or apparent conflicts.

Gary R. Lichtenstein, MD
Consulting fees/advisory boards: Abbott Laboratories, AbbVie Inc., Celgene Corporation, Ferring Pharmaceuticals Inc., Gilead Sciences, Inc., Hospira, Inc., Ironwood Pharmaceuticals, Inc., Luitpold Pharmaceuticals, Inc., Merck & Co, Inc., Mylan, Prometheus Laboratories, Inc., Romark, Salix Pharmaceuticals, Inc., Santarus Inc., Shire, Teva Pharmaceutical Industries Ltd., UCB, Inc., Valeant Pharmaceuticals International, Inc.
Contracted research: Celgene Corporation, Salix Pharmaceuticals, Inc., Santarus Inc., Shire, UCB, Inc., Valeant Pharmaceuticals International, Inc.

William F. C. Rigby, MD
Consulting fees/advisory boards: Bristol-Myers Squibb, F. Hoffman La-Roche Ltd., Merck & Co., Inc., Pfizer, Inc.
Contracted research: AbbVie Inc., Bristol-Myers Squibb, F. Hoffman La-Roche Ltd., Pfizer, Inc.

The writer, peer reviewers, and activity planners have no financial relationships to disclose.

Statement of Evidence-Based Content
Educational activities that assist physicians in carrying out their professional responsibilities more effectively and efficiently are consistent with the ACCME definition of continuing medical education (CME). As an ACCME-accredited provider of CME, it is the policy of Med-IQ to review and ensure that all the content and any recommendations, treatments, and manners of practicing medicine in CME activities are scientifically based, valid, and relevant to the practice of medicine. Med-IQ is responsible for validating the content of the CME activities it provides. Specifically, (1) all recommendations addressing the medical care of patients must be based on evidence that is scientifically sound and recognized as such within the profession; (2) all scientific research referred to, reported, or used in CME in support or justification of a patient care recommendation must conform to generally accepted standards of experimental design, data collection, and analysis.
Med-IQ is not liable for any decision made or action taken in reliance upon the information provided through this activity.

Contact Information       
For CME-related questions or comments about this activity, please contact Med-IQ.
Call (toll-free) 866 858 7434 or email info@med-iq.com.
Hardware/Software Requirements
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ADA Statement
Med-IQ fully complies with the legal requirements of the ADA and the rules and regulations thereof. If any participant in this educational activity is in need of accommodations, please contact Med-IQ at 443 543 5200.
The information provided through this activity is for continuing education purposes only and is not meant to substitute for the independent medical judgment of a physician relative to diagnostic and treatment options of a specific patient’s medical condition.

Privacy & Confidentiality
Med-IQ is committed to honoring your privacy and protecting any personal information you choose to share with us. For detailed information about our privacy notice, please visit: http://www.med-iq.com/privacy-statement/.

Acknowledgment of Commercial Support
This activity is supported by an educational grant from Pfizer, Inc.

© 2017 Med-IQ, LLC


The following material has been developed to accompany this activity:

What Do I Need to Know About Biosimilars?

Note: This material is not accredited for CME and, therefore, does not offer any CME/CE credit.

Unless otherwise indicated, photographed subjects who appear within the content of this activity or on artwork associated with this activity are models; they are not actual patients or doctors.

Need help? If you need to speak with a member of our team, please call (toll-free) 866 858 7434 or email info@med-iq.com. For technical assistance, please refer to our support manual.