Debating Interchangeability, Efficacy, and Safety of Biosimilars in the Management of Inflammatory DiseasesPremiere Date: Monday, October 30, 2017
This activity offers CE credit for:%>
- Physicians (CME)
- Pharmacists (ACPE)
All other clinicians will receive a Certificate of Attendance stating this activity was certified for AMA PRA Category 1 Credit™
Credit Expiration Date:
Tuesday, October 30, 2018
Note: Credit Is No Longer Available
|Leonard H. Calabrese, DO
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
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 Q & A session, expert faculty go in-depth answering participant 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.
At the end of this CE activity, participants should be able to:
- Distinguish biosimilars from generic agents in the management of inflammatory diseases.
- Summarize interchangeability of biosimilars with reference biologics and how it impacts clinical practice.
- Debate and evaluate the safety and efficacy of emerging biosimilars in the treatment of inflammatory diseases.
Supported by an educational grant from Pfizer Inc.
Physicians, pharmacists, physician assistants, and nurse practitioners treating patients with inflammatory diseases
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 .5 AMA PRA Category 1 CreditTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
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.
CPE Credit (Pharmacists):
CME Outfitters, LLC, is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. .5 contact hours (0.05 CEUs) Universal Activity Number: 0376-0000-17-037-H01-P
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.
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.
Jeffrey Helfand, DO, 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.
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.
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