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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 3.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Acknowledgement of Commercial Support

Supported by an independent medical education grant from Sandoz Inc., a Novartis Division.

Community Practice Connections™: Evaluating the Emerging Role of Biosimilar Agents for the Treatment of Hematologic Malignancies

Release Date: March 8, 2018
Expiration Date: March 8, 2019
Media: Internet - based


Activity Overview

Many biologic therapies serve as key components of standard-of-care management approaches for patients with hematologic malignancies, including active treatment and supportive care. However, many such biologic options are quite costly, potentially limiting the access of treatments which may improve outcomes for patients. Biosimilars are biologics that are highly similar to the reference biologic products, and they may offer the potential to bridge the treatment gap. Many health care providers lack familiarity with the complex regulatory approval process pathway for biosimilars, as well as safety and efficacy data for biosimilars that are emerging or have already been approved. This activity will provide clinicians with updates on the latest clinical advancements in biosimilar treatments for hematologic malignancies.

This activity features video interviews with leading clinical experts who will 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 in different stages of development for the management of patients with hematologic malignancies, and practical issues related to potential clinical integration.

Acknowledgement of Commercial Support

This activity is supported by an independent medical education grant from Sandoz, Inc., a Novartis Division.

CME Activity Table of Contents

  • Section I: Summary of Biosimilar Development: Differences Between Biosimilars and Generics
    Video commentary by Edward Li, PharmD, MPH, BCOP
  • Section II: Determining the Efficacy and Safety of Biosimilars
    Video commentary by Edward Li, PharmD, MPH, BCOP, and Bertrand Coiffier, MD, PhD
  • Section III: Health Agencies and Biosimilars: Regulatory Approval Process
    Video commentary by Edward Li, PharmD, MPH, BCOP, and Bertrand Coiffier, MD, PhD
  • Section IV: Integrating Biosimilars Into the Treatment of Hematologic Malignancies
    Video commentary by Pamela S. Becker, MD, PhD, and Andrew Zelenetz, MD, PhD
  • Section V: Biosimilars in Clinical Practice: Patient Education and Safety Monitoring
    Video commentary by Pamela S. Becker, MD, PhD, and Andrew Zelenetz, MD, PhD

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 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 certificate upon completion of these steps.

Target Audience

This educational activity is intended for hematologists, medical oncologists, and other health care professionals interested in the latest advances in the treatment of patients with hematologic malignancies. Fellows, researchers, nurses, nurse practitioners, physician assistants, and other health care professionals interested in the treatment of patients with hematologic malignancies are also invited to participate.

Learning Objectives

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

  • Describe the developmental process of biosimilar agents, including manufacturing complexities
  • Explain the regulatory process associated with the approval of biosimilar agents by the FDA, along with the required efficacy and safety data to support a claim that a biosimilar is as safe and effective as the reference product
  • Summarize current and emerging efficacy and safety data for biosimilar agents for the treatment of hematologic malignancies
  • Effectively counsel and communicate the impact that biosimilar agents may have on a patient’s treatment plan, while being able to integrate biosimilars into clinical practice

Faculty, Staff, and Planners' Disclosures


Edward Li, PharmD, MPH, BCOP
Professor, Department of Pharmacy Practice
University of New England College of Pharmacy
Portland, ME

Disclosure:Pfizer, Eli Lilly, Heron Therapeutics, Mylan; Speakers Bureau: Pfizer

Pamela S. Becker, MD, PhD
Professor of Medicine, Division of Hematology
University of Washington School of Medicine
Seattle, WA

Disclosure:Grant/Research Support: AbbVie, Amgen, Bristol-Myers Squibb, GlycoMimetics, JW Pharmaceutical; Consultant: Member of a Scientific Steering Committee, Pfizer; Medical Advisor, Caremark/Accordant

Bertrand Coiffier, MD, PhD
Professor of Hematology, Department of Hematology
Hospices Civils de Lyon
Université Claude Bernard
Lyon, France  

Disclosure: Grant/Research Support: Roche, Celgene; Consultant: Celltrion, Pfizer, Apobiologix, Novartis  

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 activities. In compliance with ACCME guidelines, PER® requires everyone who is in a position to control the content of a CME 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 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 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®.

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