Biosimilars in Practice – Examining the Clinical and Economic Implications to Improve Patient Care

Release Date: September 11, 2017
Expiration Date: March 31, 2019
Estimated Time to Complete Activity: 1.0 hour
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DISTINGUISHED FACULTY


	Vibeke Strand, MD, MACR, FACP Adjunct Clinical Professor, Division of Immunology/Rheumatology, Stanford University School of Medicine Biopharmaceutical Consultant Click here for biography

	Michael Zeglinski, RPh Senior Vice President, Specialty Pharmacy OptumRx^® / BriovaRx^® Click here for biography

TARGET AUDIENCE

This activity is designed to meet the educational needs of pharmacy 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, various “innovator” or “reference” biologics will lose patent protection. Consequently, interest in biosimilars or biological products highly similar to an FDA-approved biological product with no clinically meaningful differences in terms of safety and effectiveness from the reference product, is intensifying.

The anticipated access and financial benefits of biosimilars must be reconciled with the relatively low awareness of specialty pharmacy, managed care, and other pharmacy professionals of the manufacturing processes, clinical features, and regulatory requirements associated with these agents. This knowledge gap has the potential to limit utilization of these agents, thereby negating the potential advantages of adding biosimilar agents to the therapeutic arsenal.

This program will feature a clinical expert in biologics and a specialty pharmacist to discuss the latest updates in biosimilars and the impact on the daily practice of specialty pharmacists.

EDUCATIONAL OBJECTIVES

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

Explain the differences between biosimilars and reference biologics
Describe the regulatory pathway including clinical trials, approval, and labeling
Distinguish the interchangeability of biosimilars and reference biologics
Discuss the operational challenges associated with biosimilars

ACCREDITATION

Pharmacist Continuing Education


	Accreditation Statement Medical Education Resources, Inc. (MER) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Credit Designation

MER designates this continuing education activity for 1.0 contact hours (0.10 CEUs) of the Accreditation Council for Pharmacy Education. Universal Activity Number – 0816-9999-17-100-H01-P.

Type of Activity: Knowledge

DISCLOSURE OF CONFLICTS OF INTEREST
It is the policy of Medical Education Resources, Inc. (MER) to ensure balance, independence, objectivity, and scientific rigor in all of its educational activities. In accordance with this policy, MER identifies conflicts of interest with its instructors, content managers, and other individuals who are in a position to control the content of an activity. Conflicts are resolved by MER to ensure that all scientific research referred to, reported, or used in a continuing education activity conforms to the generally accepted standards of experimental design, data collection, and analysis.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this continuing education activity:

*Name of Faculty or Presenter*	*Reported Financial Relationship*
Michael Zeglinski, RPh	No financial interest/relationships relating to the topic of this activity
Vibeke Strand, MD, MACR, FACP	Consulting Fees: AbbVie, Inc., Amgen, Inc., AstraZeneca, Bayer HealthCare, Biogen, Bristol Myers-Squibb, Boehringer Ingelheim Pharmaceuticals, Inc., Celgene Corporation, Celltrion Healthcare, CORRONA, LLC, Fidia Pharma USA, Inc., Crescendo/Myriad Genetics, EMD Serono, Inc., Flexion Therapeutics, Genentech, Inc./Roche, GlaxoSmithKline, Horizon, Iroko Pharmaceuticals, Janssen, Lilly USA, LLC, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Pfizer, Inc., Regeneron Pharmaceuticals, Inc., Samsung, Samumed, Sandoz Inc., a Novartis Division, Sanofi, SKK, UCB, Inc.

The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this continuing education activity:

*Name of Planner or Manager*	*Reported Financial Relationship*
Steven Casebeer, MBA	No financial interest/relationships relating to the topic of this activity
Michael Pangrace	No financial interest/relationships relating to the topic of this activity
MER Content Managers	No financial interest/relationships relating to the topic of this activity

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
The content and views presented in this educational activity are those of the authors and do not necessarily Medical Education Resources Inc., Impact Education, LLC, and/or Sandoz Inc., a Novartis Division. The authors have disclosed if there is any discussion of published and/or investigational uses of agents that are not indicated by the FDA in their presentations. The opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of Medical Education Resources, Impact Education, LLC, and/or Sandoz Inc., a Novartis Division. Before prescribing any medicine, primary references and full prescribing information should be consulted. 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 on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. The information presented in this activity is not meant to serve as a guideline for patient management.

METHOD OF PARTICIPATION AND REQUEST FOR CREDIT
There are no fees for participating and receiving CPE credit for this activity. During the period September 11, 2017, through March 31, 2019, 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 70% or better; 4) and complete the evaluation form. Upon completion of 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.

MEDIA
Internet

FEE INFORMATION
There is no fee for this educational activity.