Continuing Education

Update on Biosimilars: An Emerging Category of Biologic Drugs

Release Date: 
10.20.12
Expiration Date: 
10.31.14
Cost: 
$0.00
CE Topic: 
Pharmacy Practice
Grant Supported: 
Amgen, Inc.

FACULTY:

John Fanikos, MBA, RPh
Assistant Director of Pharmacy
Brigham and Women’s Hospital
Assistant Professor of Clinical Pharmacy
Northeastern University, Massachusetts College of Pharmacy
Boston, Massachusetts

Kathryn Jenkins, Pharmacy Candidate
Professor of Clinical Sciences
University of Delaware, College of Arts and Sciences
Newark, Delaware

Kevin Day, Pharmacy Candidate
Department of Pharmacy Services
Brigham and Women’s Hospital
Boston, Massachusetts

FACULTY DISCLOSURE STATEMENTS:

John Fanikos, MBA, RPh, Kathryn Jenkins, Pharmacy Candidate, and Kevin Day, Pharmacy Candidate, have no relevant affiliations or financial relationships with a commercial interest to disclose.

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 STATEMENT:

ACPE

Pharmacists
Postgraduate Healthcare Education, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
UAN: 0430-0000-12-029-H01-P
Credits: 2.0 hours (0.20 CEUs)
Type of Activity: Knowledge

TARGET AUDIENCE:

This accredited activity was designed for pharmacists.

Exam processing and other inquiries and booklet orders to:
CE Customer Service: 1-800-825-4696 or cecustomerservice@powerpak.com

DISCLAIMER:

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of Postgraduate Healthcare Education or Amgen Inc. 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 evaluation of their patients’ conditions, and possible contraindications on dangers in use, (review of any applicable manufacturer’s product information) and comparison with 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.

GOAL:

The U.S. is now poised to introduce generic versions of biologics, currently referred to as biosimilars. Biosimilars are copies of therapeutic proteins intended to offer comparable safety and efficacy to the reference biologic. Controversy exists regarding whether these products are considered identical or similar and substitutable or interchangeable. Pharmacists will be managing many of these issues and playing an active role in assisting clinicians and patients with making informed health care decisions.

OBJECTIVES:

After completing this activity, the participant should be able to:

  1. Discuss the differences between biologic and biosimilar agents and how biosimilars differ from conventional small molecule generic drugs;
  2. Explain potential issues related to the storage, preparation, administration, safety, and efficacy of biosimilars;
  3. Describe the current United States (U.S.) approval pathways for biosimilars;
  4. Discuss U.S. Food and Drug Administration (FDA) requirements for establishing biosimilarity, interchangeability, and issues surrounding nomenclature and postmarketing surveillance;
  5. Discuss the introduction of biosimilars in Europe and the outstanding issues and requirements for their launch in the U.S.;
  6. Identify and discuss issues related to both product efficacy and patient safety for biologics and biosimilar agents; and
  7. Analyze pharmacoeconomic issues related to biosimilar use in the U.S.
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