Biosimilars in Practice: A Guide for Managed Care Professionals Web Activity

Release Date: February 18, 2019
Expiration Date: August 31, 2020
Estimated Time to Complete Activity: 1.5 hours
Compatible with all modern browsers and mobile devices

EXPERT FACULTY


	Edmund Pezalla, MD, MPH CEO Enlightenment Bioconsult, LLC Click here for biography

	Vanita Pindolia, PharmD, BCPS, MBA Vice President, Ambulatory Clinical Pharmacy Programs_PCM Henry Ford Health System/Health Alliance Plan of Michigan Click here for biography

	James G. Stevenson, PharmD, FASHP Professor Department of Clinical Pharmacy University of Michigan College of Pharmacy Click here for biography

TARGET AUDIENCE

Managed care pharmacy directors, clinical pharmacists, quality directors, medical directors
Pharmacy directors, specialty pharmacists, quality directors, care managers, registered nurses, and other managed care and payer organization professionals

STATEMENT OF NEED/PROGRAM OVERVIEW

Biologic drugs have revolutionized the treatment of many acute and chronic conditions by providing more effective symptom control, improved patient quality of life, and enhanced other relevant clinical and humanistic outcomes. By 2020, it is anticipated that several "innovator" or "reference" biologics will lose patent protection. Consequently, interest in biosimilar or biologic products highly similar to an FDA-approved biologic product (with no clinically meaningful differences in terms of safety and effectiveness from the reference product) is intensifying.

EDUCATIONAL OBJECTIVES
At the conclusion of this activity, participants should be able to demonstrate improved ability to:

Describe the regulatory pathway including clinical trials, approval, and labeling
Explain the differences between biosimilars and 1) reference biologics and 2) conventional generic drugs
Discuss the interchangeability of biosimilars and reference biologics
Outline the operational challenges associated with biosimilars

ACCREDITATION

Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and Impact Education, LLC. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Continuing Medical Education
The Postgraduate Institute for Medicine designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Pharmacy Education
Postgraduate Institute for Medicine designates this continuing education activity for 1.5 contact hours (0.15 CEUs) of the Accreditation Council for Pharmacy Education. (Universal Activity Number - JA4008162-9999-19-584-H04-P)

Type of Activity: Knowledge

Pharmacists have up to 30 days to complete the evaluation and claim credit for participation so that information can be submitted to CPE Monitor as required.

Continuing Nursing Education
The maximum number of hours awarded for this Continuing Nursing Education activity is 1.5 contact hours.

DISCLOSURE OF CONFLICTS OF INTEREST
Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

*Name of Faculty or Presenter*	*Reported Financial Relationship*
Vanita K. Pindolia, PharmD, BCPS, MBA	Dr. Pindolia has nothing to disclose
Edmund Pezalla, MD, MPH	Consulting fees (ex. advisory boards) – Regeneron-Sanofi Alliance
James G. Stevenson, PharmD, FASHP	Salary – Omnicell Ownership interest (stocks, stock options, or other ownership interest excluding diversified mutual funds) - Omnicell

The PIM planners and managers have nothing to disclose. The Impact Education, LLC planners and managers have nothing to disclose.

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. The planners of this activity do 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 the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer
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 patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Method of Participation and Request for Credit
There are no fees for participating and receiving CME/CE credit for this activity. During the accreditation period participants must 1) read the learning objectives and faculty disclosures; 2) study the educational activity; 3) successfully complete the post-test with a score of 75% or better; 4) and complete the evaluation form. Upon completion of the full CME/CE activity, a certificate will be made available immediately to download and print.

For Pharmacists: Upon successfully completing the post-test with a score of 75% or better and the activity evaluation, you may immediately submit your CPE credit to the NABP CPE Monitor Service. This may require you to add or update the e-profile ID/date of birth information saved in your account. Credit must be uploaded to CPE Monitor within 30 days.

MEDIA
Internet

FEE INFORMATION
There is no fee for this educational activity.