Expert Answers to Frequently Asked Questions About Biosimilars

In this CME-certified module, Robert M. Rifkin, MD, FACP, and Kenneth G. Saag, MD, MSc, provide their expert answers to your frequently asked questions about biosimilars and their application in clinical practice.
Robert M. Rifkin, MD, FACP
Kenneth G. Saag, MD, MSc
Physicians: maximum of 1.0 AMA PRA Category 1 Credit
Released: March 9, 2017 Expiration: March 8, 2018

Learning Objectives

Upon completion of this activity, participants should be able to:
  • Explain the similarities and differences among biosimilars, reference biologics, and small molecule generics
  • Compare available safety and efficacy data for biosimilars and reference biologics and the potential impact of interchangeability and substitution on dose/response, adverse events, and clinical outcomes
  • Compare and contrast the regulatory approval pathway between a reference biologic and a biosimilar

Acknowledgements

Jointly provided by Postgraduate Institute for Medicine and Clinical Care Options, LLC.
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Postgraduate Institute for Medicine
304 Inverness Way South, Suite 100
Englewood, CO 80112

Allison Hughes, CCMEP, Program Manager
(303) 799-1930
(303) 858-8842 (Fax)
ahughes@pimed.com
www.pimed.com

Supported by an educational grant from
Pfizer Inc.

Information on this Educational Activity

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 CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

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 CME activity:

Faculty

Robert M. Rifkin, MD, FACP

Clinical Associate Professor of Medicine
Division of Medical Oncology
Department of Internal Medicine
University of Colorado, Denver
Aurora, Colorado
Medical Director, Biosimilars
McKesson Specialty Health
The US Oncology Network
The Woodlands, Texas

Robert M. Rifkin, MD, FACP, has disclosed that he receives a salary from McKesson Specialty Health and has served on advisory boards for Amgen, Coherus, EMD Serono, and Pfizer.
Kenneth G. Saag, MD, MSc

Jane Knight Lowe Professor
Division of Clinical Immunology and Rheumatology
Vice Chair, Department of Medicine
Director
Center for Education and Research on Therapeutics
Center for Outcomes, Effectiveness Research and Education
Center of Research Translation in Gout and Hyperuricemia
University of Alabama at Birmingham
Birmingham, Alabama

Kenneth G. Saag, MD, MSc, has disclosed that he had received consulting fees from Abbott, Amgen, Ardea Biosciences/AstraZeneca, Bayer, Bristol-Myers Squibb, Merck, and Roche/Genentech.

Staff

Rachael M. Andrie, PhD

Clinical Editor

Rachael M. Andrie, PhD, has no real or apparent conflicts of interest to report.
Megan K. Murphy, PhD

Scientific Director

Megan K. Murphy, PhD, has no real or apparent conflicts of interest to report.
Anna Poppa

Editorial Contributor

Anna Poppa has no real or apparent conflicts of interest to report.
Jenny Schulz, PhD

Director, Scientific Services

Jenny Schulz, PhD, has no real or apparent conflicts of interest to report.
Zachary Schwartz, MSc

Scientific Director

Zachary Schwartz has no real or apparent conflicts of interest to report.
Heather Stieglitz, PhD

Editorial Contributor

Heather Stieglitz, PhD, has no real or apparent conflicts of interest to report.

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 CME activity:

The following PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, RN, BSN and Jan Schultz, RN, MSN, CHCP, hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.


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.

Target Audience

This program is intended for rheumatologists, gastroenterologists, oncologists, endocrinologists, and other healthcare professionals who are involved in the care of patients who may be eligible for treatment with biosimilars.

Goal

The goal of this activity is to improve clinicians’ understanding about biosimilars, focusing on the fundamental differences from small molecule generics and their reference biologics, as well as their safety, efficacy, and regulatory approval pathway.

Physician Continuing Medical Education

Accreditation Statement

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Postgraduate Institute for Medicine and Clinical Care Options, LLC. The Postgraduate Institute for Medicine is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation

The Postgraduate Institute for Medicine designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Program Medium

This program has been made available online.

Instructions for Credit

Participation in this self-study activity should be completed in approximately 1.0 hours. To successfully complete this activity and receive credit, participants must follow these steps during the period from March 09, 2017, through March 08, 2018:

1. Register online at http://www.clinicaloptions.com.
2. Read the target audience, learning objectives, and faculty disclosures.
3. Study the educational activity online or printed out.
4. Submit answers to the posttest questions and evaluation questions online.

You must receive a test score of at least 65% and respond to all evaluation questions to receive a certificate. After submitting the evaluation, you may access your online certificate by selecting the certificate link on the posttest confirmation page. Records of all CME/CE activities completed can be found on the "CME/CE Manager" page. There are no costs/fees for this activity.

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