Accreditation/Credit Designation

Physicians’ Education Resource®, LLC is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Physicians’ Education Resource®, LLC, 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.

Physicians' Education Resource®, LLC, is approved by the California Board of Registered Nursing, Provider #16669 for 1.5 Contact Hours.

Acknowledgment of Commercial Support

This activity is supported by educational grants from Mylan Inc. and Teva Pharmaceuticals.

Community Practice Connections™: Bridging the Gaps Around Oncology Biosimilars: Assessing the Potential Impact of Emerging Agents to Practice

Release Date: September 29, 2017
Expiration Date: September 29, 2018
Media: Internet - based


Activity Overview

As the cost of cancer therapeutics steadily rises and patents on biologic therapies for oncology near their expiration, interest in the development of lower-cost biosimilar or interchangeable biological products has increased. In March 2015, the US Food and Drug Administration (FDA) approved the first biosimilar product for use in the United States. At present, biosimilars for trastuzumab, bevacizumab, rituximab, and cetuximab are in late-phase clinical trials. The complexities of biologics and their production raise practical issues for the introduction of biosimilars compared with generic versions of traditional small-molecule drugs, including their evaluation, regulation, real-world use, nomenclature, and pharmacovigilance. Many of these issues are currently being debated and addressed by the FDA. It is critical for healthcare providers to understand these issues and the implications of regulatory decisions, and for them to be prepared to evaluate biosimilars for use in their own practice.

This activity features video interviews with leading experts who review and discuss aspects of biosimilars important to cancer care providers, including basic scientific principles of biosimilars and their production, FDA regulatory pathways and requirements, the intricacies of clinical study design and data interpretation, biosimilar agents under investigation in hematologic malignancies and solid tumors, and practical issues related to clinical integration.

Acknowledgment of Commercial Support

This activity is supported by educational grants from Mylan Inc. and Teva Pharmaceuticals.

CME/CE Activity Table of Contents

  • Biosimilars: Overview for Oncologists
    Hope Rugo, MD, and Robert Rifkin, MD
  • Development and Regulatory Approval: Focus on Cancer Therapy
    Andrew Zelenetz, MD, PhD
  • Integrating Biosimilars Into the Treatment of Hematologic Malignancies
    Robert Rifkin, MD
  • Integrating Biosimilars Into the Treatment of Solid Tumors
    Adam Brufsky, MD, PhD, and Hope Rugo, MD

Instructions for This Activity and Receiving Credit

  • You will need to login to participate in the activity.
  • Each presentation may contain an interactive question(s). You may move forward through the presentation; however, you may not go back to change answers or review videos/content until you finish the presentation.
  • At the end of the activity, “educational content/video files” will be available for your reference.
  • In order to receive a cme/ce certificate, participants must complete the activity.
  • Complete the posttest and pass with a score of 70% or higher, complete the evaluation and then click on request for credit. Participants may immediately download a cme/ce certificate upon completion of these steps.

Target Audience

This educational activity is directed toward medical oncologists. Nurse practitioners, nurses, physician assistants, pharmacists, researchers, and other healthcare professionals interested in the treatment of cancer are also invited to participate.

Learning Objectives

At the conclusion of this activity, you should be better prepared to:

  1. Summarize the developmental process of biosimilars including production complexities
  2. Describe the unique regulatory process associated with the approval of biosimilars by the FDA
  3. Interpret biosimilar efficacy and safety data from agents within and outside the US
  4. Incorporate biosimilars into clinical practice for the treatment of patients with cancer
  5. Discuss emerging agents in development for the treatment of various cancer types

Faculty, Staff, and Planners' Disclosures


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, CA

Disclosure: Grant/Research Support: GlaxoSmithKline, Genentech/Roche, Novartis, Pfizer, Merck, Eisai, Eli Lilly, OBI, MacroGenics – all funding to UC Regents only.


Adam Brufsky, MD, PhD
Professor of Medicine
Associate Chief, Division of Hematology/Oncology
Co-Director, Comprehensive Breast Cancer Center
Associate Director, Clinical Investigation
University of Pittsburgh
Pittsburgh, PA

Disclosure: Grant/Research Support: Roche; Consultant: Roche

Robert M. Rifkin, MD, FACP
Medical Director, Biosimilars
McKesson Specialty Health
The US Oncology Network
The Woodlands, TX

Disclosure: Advisory Board: Amgen, EMD Serono, Pfizer (Hospira), Coherus BioSciences

Andrew D. Zelenetz, MD, PhD
Medical Director, Quality Informatics
Attending Physician, Lymphoma Service
Department of Medicine
Memorial Sloan Kettering Cancer Center
New York, NY

Disclosure: Grant/Research Support: GlaxoSmithKline, Janssen, Roche, Gilead Sciences, Bristol-Myers Squibb; Consultant: Genentech/Roche, GlaxoSmithKline, Gilead Sciences, Celgene, Pharmacyclics/Janssen, Amgen, Takeda, NanoString Technologies, Adaptive Biotechnologies

The staff of PER® have no relevant financial relationships with commercial interests to disclose.

Disclosure Policy and Resolution of Conflicts of Interest (COI)

As a sponsor accredited by the ACCME, it is the policy of PER® to ensure fair balance, independence, objectivity, and scientific rigor in all of its CME/CE activities. In compliance with ACCME guidelines, PER® requires everyone who is in a position to control the content of a CME/CE activity to disclose all relevant financial relationships with commercial interests. The ACCME defines “relevant financial relationships” as financial relationships in any amount occurring within the past 12 months that creates a COI.

Additionally, PER® is required by ACCME to resolve all COI. PER® has identified and resolved all COI prior to the start of this activity by using a multistep process.

Off-Label Disclosure and Disclaimer

This CME/CE activity may or may not discuss investigational, unapproved, or off-label use of drugs. Participants are advised to consult prescribing information for any products discussed. The information provided in this CME/CE activity is for continuing medical and nursing education purposes only, and is not meant to substitute for the independent clinical judgment of a physician relative to diagnostic, treatment, or management options for a specific patient’s medical condition. The opinions expressed in the content are solely those of the individual faculty members and do not reflect those of PER®.

PER Pulse Recap™

PER Pulse Recap (1 of 3)

This first of 3 PER Pulse™ Recaps summarizing the online program focuses on interviews with Drs Rugo and Rifkin about biosimilar development and clinical integration, during which they discussed:
  • Prevailing misperceptions and sources of confusion among oncologists related to biosimilars
  • The status of hematology/oncology biosimilar therapeutics and pending developments
  • Their perspectives on pharmacoeconomics related to the use of biosimilars
  • Their comfort level with using biosimilars
  • Potential barriers to postapproval adoption of biosimilars in the United States
  • The importance of pharmacovigilance with clinical use of biosimilars

PER Pulse Recap (2 of 3)

This second of 3 PER Pulse™ Recaps summarizing the online program focuses on interviews with Drs Zelenetz and Brufsky about the development and regulatory approval of oncology biosimilars, during which they discussed:
  • How the development of a biosimilar for regulatory approval differs from the development of a reference molecule (eg, trastuzumab, bevacizumab, rituximab)
  • Their perspectives on the adequacy of clinical trial design in demonstrating efficacy and safety similarities between candidate biosimilars and reference products
  • Their approach toward assessing data on biosimilars
  • The significance and clinical impact of immunogenicity with biosimilars
  • Limitations of the current biosimilar development/regulatory approval pathways
  • The concepts of immunogenicity, extrapolation, interchangeability, and process changes in the context of biosimilars

PER Pulse Recap (3 of 3)

This third of 3 PER Pulse™ Recaps summarizing the online program focuses on interviews with Drs Rifkin, Rugo, and Brufsky about biosimilars for hematologic malignancies and solid tumors, during which they discussed these topics:
  • Clinical trial and real-world experiences with biosimilars in the cancer care setting
  • Candidate biosimilars in development for hematologic malignancies and solid tumors
  • Results from an assessment of the interchangeability of a candidate rituximab biosimilar with innovator rituximab
  • Findings from phase III studies of candidate trastuzumab biosimilars in breast cancer
  • Study design for the evaluation of candidate biosimilars in the settings of neoadjuvant/adjuvant versus metastatic disease
  • Their perspectives on the importance of progression-free survival and overall survival endpoints in the evaluation of candidate biosimilar molecules

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