Webcast CME

How to Obtain AMA PRA Category 1 Credit

  1. Complete the Activity.
  2. Complete the CME posttest (each question must be answered correctly).
  3. Log into your myCME account.
  4. Complete the credit and evaluation form.
  5. Print your personalized CME certificate.
  6. Credit can only be claimed once for this activity.

Technical Requirements

Biologic Therapies VI: Optimizing Therapies

Biosimilars Part 2:
Regulatory and Current Status

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Release Date: July 8, 2015
Expiration Date: July 8, 2017

Estimated Time of Completion:   15 minutes

Description

Biologic Therapies VI: Optimizing Therapies online series features an international, multi-disciplinary faculty of experts critically appraise recent basic laboratory breakthroughs in terms of their potential clinical implications and provide in-depth analyses of approved agents, new agents, predicting toxicity, clinical controversies, and new indications.

Biosimilars Part 2: Regulatory and Current Status webcast defines and describes biosimilars, as well as identifies what is required to demonstrate biosimilarity.

Learning Objectives

  1. Describe how FDA [and EMA] define a biosimilar and distinguish it from "biocopies" or "bio-mimics."
  2. Describe how biosimilars are legally regulated in the US, and how they differ from generic drugs.
  3. Outline what is required for demonstration of biosimilarity.
  4. Determine what steps are necessary to demonstrate biosimilarity.
  5. Review how many biosimilars have been approved in the United States.

Target Audience

The online series is designed for rheumatologists, dermatologists, gastroenterologists, oncologists, internal medicine physicians, and associated allied health practitioners, including nurse practitioners, nurses, and physician assistants interested in or using biologic therapeutics for autoimmune and inflammatory disorders.

Accreditation

The Cleveland Clinic Foundation Center for Continuing Education is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Cleveland Clinic Foundation Center for Continuing Education designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Participants claiming CME credit from this activity may submit the credit hours to the American Osteopathic Association for Category 2 credit.

Activity Director and Faculty

Activity Directors

Leonard Calabrese, DO
Professor of Medicine
Cleveland Clinic Lerner College of Medicine of Case Western Reserve University
R.J. Fasenmyer Chair of Clinical Immunology
Theodore F. Classen DO Chair of Osteopathic Research and Education
Orthopaedic and Rheumatologic Institute
Cleveland Clinic
Cleveland, OH

M. Elaine Husni, MD, MPH
Director, Arthritis and Musculoskeletal Treatment Center
Vice Chair, Department of Rheumatic & Immunologic Diseases
Orthopaedic and Rheumatologic Institute
Cleveland Clinic
Cleveland, OH

Faculty

Vibeke Strand, MD
Biopharmaceutical Consultant
Adjunct Clinical Professor
Division of Immunology/Rheumatology
Stanford University
Palo Alto, CA

CME Disclaimer

The information in this educational activity is provided for general medical 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. The viewpoints expressed in this CME activity are those of the authors/faculty. They do not represent an endorsement by The Cleveland Clinic Foundation. In no event will The Cleveland Clinic Foundation be liable for any decision made or action taken in reliance upon the information provided through this CME activity.

Disclosures

In accordance with the Standards for Commercial Support issued by the Accreditation Council for Continuing Medical Education (ACCME), The Cleveland Clinic Foundation Center for Continuing Education requires resolution of all faculty conflicts of interest to ensure CME activities are free of commercial bias.

The following faculty have indicated that they may have a relationship which, in the context of their presentations, could be perceived as a potential conflict of interest:

Leonard Calabrese, DO
  Abbvie, Inc.; Bristol Myers Squibb; Genentech/Roche; Janssen Scientific Affairs, LLC Consulting; Teaching and Speaking
  Crescendo Bioscience, Inc. Teaching and Speaking
  GSK; Pfizer; Inc., Sanofi Aventis; UCB, Inc. Consulting
 
Vibeke Strand, MD
  Alder; Ampio Pharmaceuticals, Inc.; Antares Pharma; AstraZeneca; BioMarin; Biotest; Carbylan; Celgene Corporation; Janssen; Merck-Serono; Regeneron; SKK; Takeda; Vertex Pharmaceuticals Consulting
  Amgen; Biogen Idec.; BMS; Crescendo Bioscience, Inc.; Genentech; GlaxoSmithKline; Idera; Incyte; Jazz Pharmaceuticals; Lilly; Novartis Pharmaceuticals; Novo Nordisk, Inc.; Pfizer; UCB Consulting; Membership on advisory committee or review panels

The following faculty has indicated she has no relationship which, in the context of her presentation, could be perceived as a potential conflict of interest:

M. Elaine Husni, MD, MPH

The Cleveland Clinic Foundation Center for Continuing Education acknowledges educational grants for partial support of this activity from:

Abbvie, Inc.
Bristol-Myers Squibb
Celgene Corporation
Crescendo Bioscience Inc.
Genentech, Inc.
Janssen Scientific Affairs, LLC
Pfizer
Questcor Pharmaceuticals, Inc.
UCB, Inc.

This CME activity was produced by Cleveland Clinic Foundation Center for Continuing Education and R.J. Fasenmyer Center for Clinical Immunology.