TARGET AUDIENCE
This educational activity has been designed to meet the educational needs of medical oncologists, hematologists, hematology-oncology fellows and other allied cancer professionals.

OVERVIEW OF ACTIVITY
The rising cost of healthcare in general and cancer care in particular has prompted growing concern in recent years about the long-term viability of the status quo. One noteworthy advance with the potential to drive down the cost of oncologic care without compromising patient outcomes is the development of biosimilar agents, and it has been projected that the introduction of “biosimilars” will reduce healthcare expenditures by up to $250 billion by 2024.

Importantly, while the market for biosimilars may be in its infancy now, widespread utilization is likely just around the corner, and oncologists must be prepared for this seemingly inevitable paradigm shift. One meaningful way clinicians can move toward this goal is through improved understanding and early adoption of biosimilar products. To facilitate and expedite such understanding and in turn facilitate the provision of high-quality, cost-effective cancer care, this educational activity focuses on the development and regulation of recently approved and investigational biosimilar agents and on available clinical research data.

LEARNING OBJECTIVES

• Evaluate the financial implications for the US healthcare system of the broad adoption of biosimilar agents in the management of various solid and hematologic cancers and related illnesses.
• Compare and contrast the discovery, development and reproduction of generic small-molecule drugs, biosimilars and their respective biologic reference agents, and use this information to counsel patients regarding the safety and efficacy of these therapies.
• Review the regulatory pathways created by the US Food and Drug Administration (FDA) to evaluate and approve biosimilars and reference biologics in order to increase confidence among cancer care professionals regarding the safety and efficacy of these agents.
• Recall available and emerging clinical research data evaluating the relative safety and efficacy of oncology biosimilars, and use this information to support the integration of these agents into the current and future care of patients with cancer.
• Summarize the “interchangeable product” designation assigned by the FDA for specific biosimilars, and explain the expected impact, or lack thereof, of product substitution on patient safety and outcomes.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
CME credit is no longer available for this issue

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
CME credit is no longer available for this issue

HOW TO USE THESE CME ACTIVITIES
Audio Program: This CME activity consists of an audio component.
CME credit is no longer available for this issue

Video Program: This CME activity consists of a video component.
CME credit is no longer available for this issue

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education. We assess conflicts of interest with faculty, planners and managers of CME activities. Conflicts of interest are identified and resolved through a conflict of interest resolution process. In addition, all activity content is reviewed by both a member of the RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty (and their spouses/partners) reported relevant conflicts of interest, which have been resolved through a conflict of interest resolution process:

Sanjiv S Agarwala, MD
Professor and Chief
Hematology and Oncology
St Luke’s Cancer Center
Temple University
Easton, Pennsylvania

Advisory Committee and Consulting Agreement: Merck.

Gary H Lyman, MD, MPH
Senior Lead, Healthcare Quality and Policy
Hutchinson Institute for Cancer Outcomes Research
Fred Hutchinson Cancer Research Center
Professor of Medicine, University of Washington School of Medicine
Seattle, Washington

Advisory Committee: G1 Therapeutics; Consulting Agreements: Amgen Inc, Helsinn Group, Hexal AG, Partners HealthCare; Contracted Research: Amgen Inc.

Hope S Rugo, MD
Professor of Medicine
Director, Breast Oncology and Clinical Trials Education
University of California, San Francisco
Helen Diller Family Comprehensive Cancer Center
San Francisco, California

Contracted Research: Eisai Inc, Genentech, Lilly, MacroGenics Inc, Merck, Novartis, OBI Pharma Inc, Pfizer Inc, Plexxikon Inc, Roche Laboratories Inc; Paid Travel: Lilly, Mylan NV, Puma Biotechnology Inc.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following commercial interests: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, Adaptive Biotechnologies, Agendia Inc, Agios Pharmaceuticals Inc, Amgen Inc, Ariad Pharmaceuticals Inc, Array BioPharma Inc, Astellas Pharma Global Development Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Biodesix Inc, bioTheranostics Inc, Boehringer Ingelheim Pharmaceuticals Inc, Boston Biomedical Pharma Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Eisai Inc, Exelixis Inc, Foundation Medicine, Genentech, Genomic Health Inc, Gilead Sciences Inc, Guardant Health, Halozyme Inc, ImmunoGen Inc, Incyte Corporation, Infinity Pharmaceuticals Inc, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Kite Pharma Inc, Lexicon Pharmaceuticals Inc, Lilly, Loxo Oncology, Medivation Inc, a Pfizer Company, Merck, Merrimack Pharmaceuticals Inc, Myriad Genetic Laboratories Inc, Natera Inc, Novartis, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Prometheus Laboratories Inc, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Sandoz Inc, a Novartis Division, Sanofi Genzyme, Seattle Genetics, Sirtex Medical Ltd, Spectrum Pharmaceuticals Inc, Taiho Oncology Inc, Takeda Oncology, Tesaro Inc, Teva Oncology and Tokai Pharmaceuticals Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant conflicts of interest to disclose.

This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantor.

This activity is supported by an educational grant from Sandoz Inc, a Novartis Division.

Hardware/Software Requirements:
A high-speed Internet connection
A monitor set to 1280 x 1024 pixels or more
Internet Explorer 11 or later, Firefox 56 or later, Chrome 61 or later, Safari 11 or later, Opera 48 or later
Adobe Flash Player 27 plug-in or later
Adobe Acrobat Reader
(Optional) Sound card and speakers for audio

Release date: February 2019
Expiration date: February 2020