CME: An Evolving Treatment Landscape for Inflammatory Disease: Debating Interchangeability, Efficacy, and Safety of Biosimilars

An Evolving Treatment Landscape for Inflammatory Disease: Debating Interchangeability, Efficacy, and Safety of Biosimilars

An Evolving Treatment Landscape for Inflammatory Disease: Debating Interchangeability, Efficacy, and Safety of Biosimilars
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Expert faculty discuss evidence, guidelines, and quality measures for implementing biosimilars in patients with inflammatory diseases.

Available credits: 1.50

Time to complete: 1.5 hours

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  • Overview

    Statement of Need

    Healthcare spending has grown much faster than the rest of the economy, and this trend is seemingly unsustainable.1 Biologic agents are highly effective against inflammatory diseases, but may be restricted by many healthcare plans due to cost. Biosimilars offer a potential solution as a cost-effective alternative to biologic agents. Biosimilars have been available in Europe since 2005. In the United States, the first biosimilar to be approved was filgrastim, a human granulocyte colony-stimulating factor. The first biosimilar to be approved for inflammatory diseases was the monoclonal antibody, infliximab-dyyb. Infliximab-dyyb was approved in April of 2016 for rheumatoid arthritis (RA), adult ulcerative colitis (UC), psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis (AS), and adult and pediatric Crohn’s disease (CD). Since then, 3 additional biosimilars have been approved in the United States and many others are in development. 

    A biosimilar is a “biopharmaceutical that is genetically engineered, designed to be highly similar to an existing approved biologic product. Highly similar means that any difference is minor and not considered to be clinically meaningful. Biosimilars are expected to have biologic activity similar to that of existing, approved biopharmaceuticals and comparable efficacy and safety based on a full assessment that includes analytical, preclinical, pharmacokinetics (PK), pharmacodynamics (PD), and clinical studies.”2 

    In this CME Outfitters live Q & A session, expert faculty will go in-depth answering your questions while offering evidence, guidelines, and quality measures for collaborative strategies to optimally use biosimilars in patients with inflammatory diseases. 

    1. Feagan BG. Debate: biosimilars - use as indicated, in place of our current biologics. Presented at: 2015 Advances in Inflammatory Bowel Diseases: Crohn’s & Colitis Foundation’s Clinical & Research Conference; December 6-9, 2015. 

    2. Kay J. A primer on biosimilars: how do biosimilars compare with reference biologics and generics? Medscape Website. http://www.medscape.org/viewarticle/837696. Published May 28, 2015. Accessed August 1, 2016.

  • Faculty

    Leonard H. Calabrese, DO (Moderator)
    Professor of Medicine
    Vice Chair, Department of Rheumatic & Immunologic Disease
    Cleveland Clinic Lerner College of Medicine
    of Case Western Reserve University
    R.J. Fasenmyer Chair of Clinical Immunology
    Cleveland Clinic Foundation
    Cleveland, OH

    Russell D. Cohen, MD, FACG, AGAF 
    Professor of Medicine, Pritzker School of Medicine
    Director, Inflammatory Bowel Disease Center
    Co-Director, Advanced IBD Fellowship Program
    University of Chicago Medicine
    Chicago, IL

    Edward Li, PharmD, MPH, BCOP  
    Professor
    University of New England College of Pharmacy
    Portland, ME

  • Learning Objectives

    At the end of this CE activity, participants should be able to:

    • Summarize interchangeability of biosimilars with reference biologics and how it impacts clinical practice.
    • Distinguish biosimilars from generic agents in the management of inflammatory diseases.
    • Debate and evaluate the safety and efficacy of emerging biosimilars in the treatment of inflammatory diseases.
  • Financial Support

    Supported by an educational grant from Pfizer Inc.

  • Target Audience

    Physicians, pharmacists, physician assistants, nurse practitioners, and nurses treating patients with inflammatory diseases.

  • Credit Information

    CME Credit (Physicians):
    CME Outfitters, LLC, is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. 

    CME Outfitters, LLC, designates this enduring material for a maximum of 1.5 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    CNE Credit (Nurses):
    Provider approved by the California Board of Registered Nursing, Provider Number CEP 15510, for 1.5 contact hours 

    Note to Nurse Practitioners and Clinical Nurse Specialists: the content of this activity pertains to pharmacology.  Earn up to 1.5 contact hours of pharmacotherapeutic contact hours. 

    Note to Nurse Practitioners: Nurse practitioners can apply for AMA PRA Category 1 CreditTM through the American Academy of Nurse Practitioners (AANP). AANP will accept AMA PRA Category 1 Credit(s)TM from organizations accredited by the Accreditation Council for Continuing Medical Education. Nurse practitioners can also apply for credit through their state boards.

    CPE Credit (Pharmacists):

    CME Outfitters, LLC, is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. 1.5 contact hours (0.15 CEUs) Universal Activity Number: 
    Enduring: 0376-0000-17-031-H01-P 

    Type: Knowledge-based

    Note to Physician Assistants: AAPA accepts certificates of participation for educational activities certified for AMA PRA Category 1 CreditTM from organizations accredited by the Accreditation Council for Continuing Medical Education. 

    Post-tests, credit request forms, and activity evaluations must be completed, and participants can print their certificate or statement of credit immediately (75% pass rate required). For complete technical requirements and privacy policy, visit www.neurosciencecme.com/technical.asp.

  • Disclosure Declaration

    It is the policy of CME Outfitters, LLC, to ensure independence, balance, objectivity, and scientific rigor and integrity in all of their CE activities. Faculty must disclose to the participants any relationships with commercial companies whose products or devices may be mentioned in faculty presentations, or with the commercial supporter of this CE activity. CME Outfitters, LLC, has evaluated, identified, and attempted to resolve any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process. The following information is for participant information only. It is not assumed that these relationships will have a negative impact on the presentations. 

    Dr. Calabrese reports that he is a consultant for AbbVie Inc.; Centecor Biopharmaceutical; GlaxoSmithKline; Horizon Pharma; Janssen Pharmaceuticals, Inc.; Pfizer Inc.; Regeneron Pharmaceuticals, Inc.; and UCB, Inc. 

    Dr. Cohen reports that he is serves as consultant / advisory / scientific advisory board for AbbVie Inc.; Celgene Corporation; Eli Lilly and Company; Hospira, Inc.; Janssen Research & Development, LLC (Johnson & Johnson / Centocor); Pfizer Inc.; Sandoz Biopharmaceuticals; Takeda Pharmaceuticals U.S.A., Inc. and UCB, Inc. He is the principal investigator in clinical trials for AstraZeneca; Celgene Corporation; Gilead Sciences, Inc.; Medimmune; Mesoblast Ltd.; Osiris Therapeutics, Inc.; Pfizer Inc.; Receptos, Inc.; RedHill Biopharma; Sanofi-Aventis and UCB, Inc. He serves on speakers bureau for AbbVie Inc. and Takeda Pharmaceuticals U.S.A., Inc. He has disclosed his spouse is on the board of directors for Protein Sciences Corporation; Tokai Pharmaceuticals, Inc.; Vital Therapies, Inc. and CytRx Corporation.

    Dr. Li reports that he serves on speakers bureau for Apobiologix and Pfizer Inc. He serves as consultant for Mylan and Pfizer Inc.

    Jeffrey Helfand, DO, MS (peer reviewer) has no disclosures to report.

    Kimberley Murray, RN, MS (peer reviewer) has no disclosures to report.

    Daniela V. DiBiase, MS (planning committee) has no disclosures to report. 

    Sharon Tordoff, CHCP (planning committee) has no disclosures to report. 

    Disclosures were obtained from the CME Outfitters, LLC staff: No disclosures to report. 

    Faculty of this CE activity may include discussions of products or devices that are not currently labeled for use by the FDA. The faculty have been informed of their responsibility to disclose to the audience if they will be discussing off-label or investigational uses (any uses not approved by the FDA) of products or devices. 

    Questions about this activity? Call us at 877.CME.PROS(877.263.7767).

  • System Requirements

    Our site requires a computer, tablet or mobile device and a connection to the Internet. For best results, a high-speed Internet connection is recommended (DSL/cable). We also recommend using the latest version of your favorite browser to ensure compliance with W3C standards, such as Internet Explorer, Microsoft Edge, Chrome, Firefox or Safari. Users accustomed to IE8, IE9 IE10 are advised to update their browsers for the best experience.

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