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Biosimilars in Oncology: Current Status, Future Directions, and Clinical Considerations
This educational activity is sponsored by Postgraduate Healthcare Education, LLC (PHE) and supported by an educational grant from Amgen.
Bernard L. Marini, PharmD, BCOP
Department of Pharmacy
Michigan Medicine, University of Michigan
Ann Arbor, MI
James G. Stevenson, PharmD, FASHP, FFIP
Professor, Department of Clinical Pharmacy
University of Michigan College of Pharmacy
Ann Arbor, MI
Bernard L. Marini, PharmD, BCOP and James G. Stevenson, PharmD, FASHP, FFIP hereby state that they have no relevant affiliation or financial relationship or relationship to products or devices with a commercial interest related to the content of this activity to disclose.
The following reviewer, Steven Kheloussi, PharmD, hereby states he has no relevant affiliation or financial relationship or relationship to products or devices with a commercial interest related to the content of this activity to disclose.
Susanne Batesko, RN, BSN, Robin Carrino, and L. Michael Posey, BSPharm, MA, 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. PHE is committed to providing participants with a quality learning experience and to improve clinical outcomes without promoting the financial interests of a proprietary business.
Postgraduate Healthcare Education, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Credits: 2.0 hour (0.2 ceu)
Type of Activity: Knowledge
Fee Information: There is no fee for this educational activity.
Estimated time to complete activity: 120 minutes
November 30, 2018
November 30, 2020
This accredited activity has been designed for pharmacists.
HOW TO EARN CREDIT
During the period November 30, 2018, through November 30, 2020, 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 Grade Exam 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.
To inform and educate pharmacists about incorporation of oncology biosimilars into clinical practice, with an emphasis on key issues and challenges, newly FDA-approved agents, and agents in clinical development.
Upon completion of this activity, participants should be better able to:
- Describe the regulatory requirements for oncology biosimilars while in development and once approved by the Food and Drug Administration
- Explain key issues and challenges with oncology biosimilars, including interchangeability, approved indications and extrapolation, and safety information
- Discuss clinical efficacy and safety data with bevacizumab-awwb and trastuzumab-dkst
- Explain efficacy and safety data with biosimilars in late stages of clinical development
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
- Peripherals: Computer speakers or headphones
- 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 Amgen. 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.