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FACULTY

Nora I. Osemene, RPh, MS, PharmD
Professor and Associate Dean for Academic Affairs
Texas Southern University College of Pharmacy and Health Sciences
Houston, Texas

FINANCIAL DISCLOSURE

Nora I. Osemene, RPh, MS, PharmD , has indicated that she has no relevant affiliations or financial relationships with a commercial interest to disclose.

The following reviewer, Duane M. Kirking, PharmD, PhD, hereby states that he does not have any financial relationships or relationships to products or devices with a commercial interest related to the content of this activity.

Susanne Batesko, RN, BSN, Michele Salernitano, and Robin Carrino, as well as the planners, managers, and other individuals, not previously disclosed, who are in a position to control the content of Postgraduate Healthcare Education (PHE) continuing education (CE) activities hereby state that they have no relevant conflicts of interest and no financial relationships or relationships to products or devices during the past 12 months to disclose in relation to this activity. We are committed to providing participants with a quality learning experience and to improve clinical outcomes without promoting the financial interests of a proprietary business.

ACCREDITATION STATEMENTS

PHARMACY
Postgraduate Healthcare Education, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
UAN: 0430-0000-15-079-H01-P

Credits: 2.0 hours (0.20 ceu)
Published: December 18, 2015
Expires: December 31, 2017
Type of Activity: Knowledge
Media: Internet
Fee Information: There is no fee for this educational activity.
Estimated time to complete activity: 120 minutes

TARGET AUDIENCE

This accredited activity has been designed for pharmacists.

HOW TO EARN CREDIT

During the period December 18, 2015 through December 31, 2017, participants must 1) read the learning objectives and faculty disclosures; 2) study the educational activity; and 3) complete the post-test and the evaluation form. To answer the questions, click on your selected choice for each answer then proceed to the next question. Once completed, click on Submit Post-test at the bottom of the page. Your post-test will automatically be graded. If you successfully complete the post-test (score of 70% or higher), your statement of participation will be made available immediately. Click on the View Statement of Participation link and print the statement for your records. If you receive a score lower than 70%, you will receive a message notifying you that you did not pass the post-test. You will have 2 opportunities to pass the post-test. To receive Credit, you must provide your date of birth and NABP number. All Credit information will be uploaded into CPE monitor within 30 days.

GOAL

To inform and educate pharmacists in a variety of practice settings about the implications and key issues surrounding the development and eventual distribution of biosimilar therapeutic agents in the United States.

EDUCATIONAL OBJECTIVES

Upon completion of this activity, participants should be better able to:

1. Discuss the differences between biologic drugs and biosimilar agents;
2. Explain the process and standards associated with biosimilar development and approval in the United States;
3. Discuss rationale for development of biosimilar filgrastim and compare this agent with the reference product;
4. Assess issues relating to the clinical safety and efficacy of biologics and biosimilar agents; and
5. Analyze pharmacoeconomic issues relating to biosimilar use in the United States.

REQUIRED COMPUTER HARDWARE/SOFTWARE

Please ensure the computer system you plan to use meets the following minimum requirements:

• Operating System: Windows 98 or higher & Macintosh 2.2 or higher
• Internet Browser (Mac &/Windows): Internet Explorer 6.0 or higher, Google Chrome, Safari 5.0.6 or higher, Firefox 3.0.3 or higher & Opera 5 or higher
• Broadband Internet connection: Cable, High-speed DSL & any other medium that is internet accessible
• Monitor Screen Resolution: 320 x 480 or higher
• Media Viewing Requirements: Adobe Reader, Microsoft PowerPoint, Flash Player & HTML5

Disclosure of Unlabeled Use and Disclaimer


The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of Postgraduate Healthcare Education, LLC and Sandoz. 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 an evaluation of their patients' conditions and current medications, including the identification of possible contraindications regarding the dangers of use and a review of any applicable manufacturer's product information, as well as a comparison with the recommendations of other authorities.

The author, sponsor, and publisher of this continuing education activity have made all reasonable efforts to ensure that all information contained herein is accurate in accordance with the latest available scientific knowledge at the time of acceptance for publication. However, because information regarding drugs (their administration, dosages, contraindications, adverse reactions, interactions, special warnings, precautions, etc.) is subject to constant change, the reader is advised to check the manufacturer's package insert for information concerning recommended dosages and potential problems and cautions prior to dispensing or administering the drug. Special precautions should be taken when a drug is new, or highly toxic, or is unfamiliar to the dispenser or administrant. This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the U.S. Food and Drug Administration (FDA). Neither the publisher nor sponsor promotes the use of any agent outside of approved labeling. Statements made in this monograph have not been evaluated by the FDA. Nutritional products discussed are not intended for the diagnosis, treatment, cure, or prevention of any disease.