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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

Format

Webcast

Time to Complete

1.50 hours

Released

July 27, 2017

Expires

July 27, 2018
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Maximum Credits

1.50 / AMA PRA Category 1 CreditsTM
1.50 / CE for Nurses
1.50 / CE for Pharmacists (0.015 CEUs)

Accredited Provider


This educational initiative is provided by CME Outfitters.

Commercial Supporter

This activity is supported by an educational grant from Pfizer Inc.

Program Description

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.
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References
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.

Intended Audience

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

Educational 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

Conflict Of Interest Disclosure Policy

It is the policy of CME Outfitters, LLC, to ensure independence, balance, objectivity, and scientific rigor and integrity in all of their CME/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 CME/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.

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

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.

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

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 the 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.

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

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

Accredited Provider Disclosure

The CME Outfitters, LLC staff has nothing to disclose.

Planners' and Managers' Disclosures

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 (planning committee) has no disclosures to report.

Credit

1.50

Type

AMA PRA Category 1 Credit(s)TM

Accreditation Statement

CME Outfitters, LLC is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Designation Statement

CME Outfitters, LLC, designates this enduring material for a maximum of 1.50 AMA PRA Category 1 CreditsTM  . Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Credit

1.50

Type

CE for Nurses

Accreditation Statement

CME Outfitters, LLC, is approved by the California Board of Registered Nursing.

Designation Statement

Provider approved by the California Board of Registered Nursing, Provider Number CEP 15510 for 1.50 contact hour.

Credit

1.50

Type

CE for Pharmacists

Accreditation Statement

CME Outfitters, LLC, is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. 1.50 contact hours (0.15 CEUs)
Universal Activity Number: 0376-0000-17-031-H01-P
Activity Type: knowledge-based

Additional Credit Information

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 CreditTM   from organizations accredited by the Accreditation Council for Continuing Medical Education. Nurse practitioners can also apply for credit through their state boards.

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.

Disclosure of Unlabeled Use

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.


Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Instructions

There are no fees for participating in this CME/CE activity. To receive credit, participants must (1) read the learning objectives and disclosure statements, (2) study the educational activity, and (3) complete the post-test and activity evaluation form, including the certificate information section.

To obtain a certificate, participants must receive a score of 75% or better on the post-test. The post-test can be accessed at the end of the activity. Your online certificate will be saved on myCME within your Profile/CME History, which you can access at any time.

If you have any questions relating to the accreditation of this activity, please contact info@cmeoutfitters.com.

If you have any other questions relating to your certificate or other issues with this activity, please contact myCME.Support@haymarketmedical.com.

SYSTEM REQUIREMENTS

Hardware and Software Requirements
  • A computer with an internet connection
  • Internet Browser: Internet Explorer 7.x or higher, Firefox 4.x or higher, Safari 2.x or higher, or any other W3C standards compliant browser
  • Additional Software: Adobe Flash Player and/or an HTML 5 capable browser maybe required for video or audio playback. PowerPoint or Adobe Acrobat Reader may occasionally be required
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