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Evaluating Biosimilars: A Value Proposition for Health Systems, Hospitals, Practices and Payers (Law)


Description:
This activity will examine the science of biosimilars, focusing on the differences between them and more common generics, how they will be evaluated by the FDA, and how that will cause the pharmacist to review them differently than generics. Important components of the institutional review process will also be discussed along with a check list of all items that should be reviewed prior to P&T committee approval.
 
Objectives:
1. Summarize the differences between biosimilars and common generic pharmaceuticals.
2. Describe the biosimilar approval process and associated regulations.
3. Explain the value provided by biosimilars and the various stake holders involved.
4. Describe the institutional review process and the various types of actions which can be taken to
   manage drug use.
5. List 3 major critical categories that would be part of a ‘checklist’ for the review of a biosimilar
    product.
 
Activity Number:
0280-0000-16-078-H03-P
 
This recorded activity is a based on a live program that was offered on October 14, 2016 in Burlington, MA.  
Participants who received credit for the live program should not claim credit for this web based presentation.
 
System Requirements for Participants:
Operating system:  Windows XP, Vista or 7  MAC OS X • Latest Version of Adobe Reader
Browser Internet Explorer 8.0 or above  Google Chrome 16.0 or above  Firefox 7.0 or above  Safari 5.0 or above
 

Fee

$0.00

CE Hours

1.00

CE Units

0.100

Activity Type

  • Knowledge Based

Target Audience(s)

  • Pharmacists

Accreditation(s)

Accreditation Council for Pharmacy Education
American Health Resources is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education

Requirements for CE Credit

  • Complete the pre-test
  • Review the content of this activity
  • Successfully complete the post-test with a score of 80% or higher 
  • Complete activity evaluation
Continuing pharmacy education credit is automatically reported to CPE Monitor once the post-test & evaluation is completed.
 
Pharmacists - Be sure your profile has been updated with your NAPB e-profile # and birth date information BEFORE completing the online evaluation, or your credits will NOT be reported.

Support/Credits

Disclosures:
The presenter is Jim Koeller, MS, RPh;  Professor, University of Texas at Austin College of Pharmacy, Pharmacotherapy Division
Mr. Koeller is on the speaker’s bureau of Pfizer and is a consultant for Apobiologics
 
The reviewer is Susanne E Liewer, PharmD, BCOP; Clinical Pharmacy Coordinator, Stem Cell Transplant, The Nebraska Medical Center, Omaha, Nebraska
Dr Liewer does not have any relevant financial relationships with any commercial interests.
 
 
Support for This Activity:
This activity is supported by the Association of Community Cancer Centers (ACCC).
 
American Health Resources assesses conflict of interest with its instructors, reviewers and other individuals who are in a position to control the content of CE activities. All relevant conflicts of interest that are identified are resolved by American Health Resources for fair balance and scientific objectivity.
 
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA.  American Health Resources does not recommend the use of any agent outside of the labeled indications.  The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of American Health Resources.  Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

 

 

 

This activity will examine the science of biosimilars, focusing on the differences between them and more common generics, how they will be evaluated by the FDA, and how that will cause the pharmacist to review them differently than generics. Important components of the institutional review process will also be discussed along with a check list of all items that should be reviewed prior to P&T committee approval.
 

Objectives

  • Summarize the differences between biosimilars and common generic pharmaceuticals.
  • Describe the biosimilar approval process and associated regulations.
  • Explain the value provided by biosimilars and the various stake holders involved.
  • Describe the institutional review process and the various types of actions which can be taken to manage drug use.
  • List 3 major critical categories that would be part of a ‘checklist’ for the review of a biosimilar product.

Speaker(s)/Author(s)

Jim Koeller, MS picture

Jim Koeller, MS
Professor, Pharmacotherapy Division, University of Texas at Austin College of Pharmacy


Brief Bio : Professor Koeller received his undergraduate and graduate degrees from the University of Wisconsin-Madison, and completed a residency at the University of Wisconsin Hospital. Professor Koeller is currently a full professor and member of the Center for Pharmacoeconomic Studies in the College of Pharmacy at the University of Texas at Austin, where he holds the Eli Lilly/CR Sublett Endowed Fellowship in Pharmacy. In addition, Professor Koeller is an Adjoint Professor of Medicine and Oncology at the University of Texas Health Science Center in San Antonio. Prior to moving to Texas, he spent 5 years coordinating the Phase I Drug Development Program in the Department of Human Oncology, Wisconsin Comprehensive Cancer Center in Madison, Wisconsin. Professor Koeller’s research interests are in the areas of pharmacoeconomics, outcomes and health services research. A significant portion of his research is in the area of oncology. His team has established the cost of care for non-small cell lung cancer, breast cancer and head and neck cancer. His team has also quantitated the value of using pathways in oncology, identified risk groups in the aids population and established the clinical utility of genomics testing in the Medicare population. He has published over 250 articles, abstracts, and book chapters in the areas of oncology practice, pharmacoeconomics, new drug development, and supportive care issues of the cancer patient. In addition, he has given over 500 presentations related to oncology, supportive care, biosimilars, pharmacoeconomics, cancer disease management, pathway development and outcome measurement, quality & value in cancer care, and general cancer care economics.

Activity Number

0280-0000-16-078-H03-P

Release Date: Nov 9, 2016
Credit Expiration Date: Nov 9, 2018

CE Hours

1.00

Fee

$0.00