Overview
Leonard Calabrese, DO, and Edward Li, PharmD, MPH, BCOP, discuss how to interpret the efficacy and safety data for biosimilar products, and the implications of biosimilars for clinical practice.
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Read the activity transcript.
Content Areas
- Pharmacoeconomic impact
- Burden of evidence
- Interpreting clinical evidence
- Practice implications
Target Audience
Rheumatologists, oncologists, dermatologists, gastroenterologists, nephrologists, pharmacists, and other clinicians who currently use or may consider using biosimilars in clinical practice.
Faculty
Professor of Medicine
Cleveland Clinic Lerner College of Medicine
Director, RJ Fasenmyer Center for Clinical Immunology
Cleveland Clinic
Cleveland, Ohio
Associate Professor
Department of Pharmacy Practice
University of New England College of Pharmacy
Portland, Maine
Slides
Activity - Print Version| Available Credit: |
1.00 AMA PRA Category 1 Credit™. 1.00 ACPE Contact Hour |
| Opens: | May 26, 2017 |
| Expires: | May 25, 2018 |
| Target Audience: |
Rheumatologists Oncologists Dermatologists Gastroenterologists Nephrologists Pharmacists Other Health Care Providers |
CE/CME STATEMENT
Target Audience
Rheumatologists, oncologists, dermatologists, gastroenterologists, nephrologists, pharmacists, and other clinicians who currently use or may consider using biosimilars in clinical practice.
Learning Objectives
At the conclusion of this activity, participants should be better able to:
- Recognize manufacturing differences between biosimilars and their references biological product as well as generic small molecule drugs
- Describe how the FDA uses a "totality of evidence" strategy to evaluate biosimilar compounds
- Assess the efficacy and safety data for biosimilar products in relation to the data for their reference biological products
- Consider how the availability of biosimilars will impact clinical practice
Faculty
Professor of Medicine
Cleveland Clinic Lerner College of Medicine
Director, RJ Fasenmyer Center for Clinical Immunology
Cleveland Clinic
Cleveland, Ohio
Associate Professor
Department of Pharmacy Practice
University of New England College of Pharmacy
Portland, Maine
Accreditation and Certification
The Annenberg Center for Health Sciences at Eisenhower is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
The Annenberg Center for Health Sciences at Eisenhower designates this enduring material for a maximum of 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
The
Annenberg Center for Health Sciences at Eisenhower is accredited by the Accreditation Council for
Pharmacy Education as a provider of continuing pharmacy education. This program has been assigned
ACPE Universal Program 0797-0000-17-022-L04-P. This program is designated for up to
1.00 contact hour (0.1 CEU) of continuing pharmacy education credit.
Disclosure Statement
It is the policy of the Annenberg Center for Health Sciences to ensure fair balance, independence, objectivity, and scientific rigor in all programming. All faculty and planners participating in sponsored programs are expected to identify and reference off-label product use and disclose any relationship with those supporting the activity or any others with products or services available within the scope of the topic being discussed in the educational presentation.
The Annenberg Center for Health Sciences assesses conflict of interest with its instructors, planners, managers, and other individuals who are in a position to control the content of CE/CME activities. All relevant conflicts of interest that are identified are thoroughly vetted by the Annenberg Center for fair balance, scientific objectivity of studies utilized in this activity, and patient care recommendations. The Annenberg Center is committed to providing its learners with high-quality CE/CME activities and related materials that promote improvements or quality in health care and not a specific proprietary business interest of a commercial interest.
In accordance with the Accreditation Council for Continuing Medical Education Standards, parallel documents from other accrediting bodies, and Annenberg Center for Health Sciences policy, the following disclosures have been made:
Leonard Calabrese, DO
- Consultant: BioGen, Bristol-Myers Squibb, Genentech, GSK, Regeneron
- Speakers Bureau: Abbvie, Crescendo, Geron, Janssen
Edward Li, PharmD, MPH, BCOP
- Consultant: Eli Lilly, Pfizer
- Speakers Bureau: Apobiologix, Pfizer
The faculty for this activity has disclosed that there will be no discussion about the use of products for non-FDA approved indications.
Additional Content Planners
Alex Howson, MA, PhD (medical writer): No significant relationships to disclose
Annenberg Center for Health SciencesJohn Bayliss, VP, Business Development, spouse is an employee of Amgen, Inc; all other staff at the Annenberg Center for Health Sciences at Eisenhower have no relevant commercial relationships to disclose.
The ideas and opinions presented in this educational activity are those of the faculty and do not necessarily reflect the views of the Annenberg Center and/or its agents. As in all educational activities, we encourage practitioners to use their own judgment in treating and addressing the needs of each individual patient, taking into account that patient's unique clinical situation. The Annenberg Center disclaims all liability and cannot be held responsible for any problems that may arise from participating in this activity or following treatment recommendations presented.
This educational activity is supported by an independent medical educational grant from Pfizer.
This activity is an online enduring material. Successful completion is achieved by reading and/or viewing the material, reflecting on its implications in your practice, and completing the assessment component.
The estimated time to complete the activity is 1.00 hour.
This activity was originally released on May 26, 2017 and is eligible for credit through May 25, 2018.
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