Activity Description and Educational Objectives

In this activity, a leading expert discusses key concepts on biosimilars, including how they are defined, the FDA approval process for these agents, and an overview of data for some biosimilars currently available in the US. Important considerations for managed care professionals regarding these treatments, such as formulary inclusion, costs, as well as provider and patient education, are also explored.

Upon completion of this activity, participants will be able to:

• Discuss foundational concepts regarding biosimilars, including structure, clinical properties, regulation, extrapolation of indications, and interchangeability
• Evaluate clinical evidence on the efficacy, safety, immunogenicity, and cost effectiveness of biosimilars available in the US market

Target Audience

This activity has been designed to meet the educational needs of managed care professionals.

Requirements for Successful Completion

In order to receive credit, participants must view the activity and complete the post-test and evaluation form. There are no pre-requisites and there is no fee to participate in this activity or to receive CME/CPE credit. Statements of Credit are awarded upon successful completion of the post-test and evaluation form.

Media: Enduring Material
Release and Expiration Dates: October 06, 2017 - October 05, 2018
Time to Complete: 30 minutes

Faculty & Disclosure / Conflict of Interest Policy

All faculty AND staff involved in the planning, review or presentation of continuing education activities provided by Purdue University College of Pharmacy are required to disclose to the audience any relevant commercial financial affiliations related to the content of the presentation or enduring material. Full disclosure of all commercial relationships must be made in writing to the audience prior to the activity.

Course Director

Stanley Cohen, MD
Medical Director, Metroplex Clinical Research Center
Clinical Professor, Internal Medicine
UT Southwestern Medical School
Director, Rheumatology Division
Presbyterian Hospital
Dallas, Texas

Stanley Cohen, MD, has a financial interest/relationship or affiliation in the form of:
Grant/Research Support from AbbVie Inc.; Amgen Inc.; AstraZeneca; Biogen; Bristol-Myers Squibb Company; Eli Lilly; F. Hoffmann-La Roche Ltd; Genentech, Inc.; Janssen Pharmaceuticals, Inc.; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; and Pfizer Inc.

CME Reviewer

Ashley H. Vincent, PharmD, BCACP, BCPS
Clinical Associate Professor
Purdue University College of Pharmacy
West Lafayette, Indiana

Ashley H. Vincent, PharmD, BCACP, BCPS, has a financial interest/relationship or affiliation in the form of:
Speakers Bureau participant with FreeCE.com, American College of Clinical Pharmacy.
Honorarium from FreeCE.com, American College of Clinical Pharmacy.

Medical Director

Kate Nelson, PhD
PVI, PeerView Institute for Medical Education

Kate Nelson, PhD, has no financial interests/relationships or affiliations in relation to this activity.

All additional planning committee members and reviewers, PVI, PeerView Institute for Medical Education, Inc. staff, and Purdue University College of Pharmacy staff have no relationships to disclose.

Providership, Credit & Support

Physicians

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Purdue University College of Pharmacy and PVI, PeerView Institute for Medical Education. Purdue University College of Pharmacy, an equal access/equal opportunity institution, is accredited by the ACCME to provide continuing medical education for physicians.

The Purdue University College of Pharmacy designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Pharmacists

Purdue University College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This is a knowledge-based, continuing education activity of Purdue University, an equal access/equal opportunity institution. Universal Activity Number (UAN): 0018-9999-17-064-H04-P, 0.5 contact hours (0.05 CEUs).
Release Date: October 06, 2017 Expiration Date: October 05, 2018

Providership

This CME/CPE activity is jointly provided by Purdue University College of Pharmacy and PVI, PeerView Institute for Medical Education.

Support

This activity is supported by an educational grant from Pfizer.

Disclosure of Unlabeled Use

The faculty of this educational activity may include discussions of products or devices that are not currently labeled for use by the FDA. Faculty members have been advised to disclose to the audience any reference to an unlabeled or investigational use.

No endorsement of unapproved products or uses is made or implied by coverage of these products or uses in our reports. No responsibility is taken for errors or omissions in reports.

Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings.

The materials presented here are used with the permission of the authors and/or other sources. These materials do not necessarily reflect the views of PeerView Press or any of its partners, providers, and/or supporters.

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