The Rapidly Evolving Role of Biosimilars: Educating Specialists and Facilitating Shared Decision Making With Patients
Sanjiv S. Agarwala, MD
Professor and Chief
Hematology & Oncology
St. Luke’s Cancer Center
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
William F. C. Rigby, MD
Professor of Medicine, Microbiology, and Immunology
Director of Rheumatology Research
The Geisel School of Medicine at Dartmouth
Christie Avraamides, PhD
Clinical Content Manager
Rebecca L. Julian, MS, ELS
Senior Manager, Editorial
Kathryn Schaefer, MSN, RN
Lead Nurse Planner
Lori K. Pender, PharmD, MPH, BCOP, ELS
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
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.
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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
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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.
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Acknowledgment of Commercial Support
This activity is supported by an educational grant from Pfizer, Inc.
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