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.

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Acknowledgement of Commercial Support

This activity is supported by an educational grant from Pfizer.

Advent of Oncology Monoclonal Antibody Biosimilars ‒ A European Perspective Online

Release Date: November 30, 2017
Expiration Date: November 30, 2018
Media: Internet - based


Activity Overview

The European Medicines Agency (EMA) has approved more than 37 biosimilars since developing guidelines and recommendations for evaluation of these agents. As biologic products lose patent exclusivity, and more biosimilar monoclonal antibodies receive regulatory approval, it will be necessary for healthcare providers to understand the key concepts and issues involved in biosimilar development so they can make informed decisions when adopting these agents into their clinical practice. This is especially critical because multiple biosimilars of the same product are likely to become available. It is also important to be clear about whether a specific product has been evaluated through a rigorous evaluation procedure, based on the criteria defined in the EMA biosimilar guidelines, and for prescribers to understand what happens when a biosimilar receives a designation of “interchangeable” with the originator and when substitution may occur, as these designations/policies may impact patient outcomes.

Advent of Oncology Monoclonal Antibody Biosimilars ‒ A European Perspective is an archive of a live video webcast, created and broadcast in real-time to a European audience. Its goal is to educate European pharmacists and physicians about the advantages of the emerging curative oncology biosimilars in terms of their potential to reduce the acquisition cost of cancer drugs, thereby increasing affordability and patient access.

Acknowledgement of Commercial Support

This activity is supported by an educational grant from Pfizer.

CME/CE Activity Table of Contents

  • Welcome and Introductions
  • Biosimilars: Overview for Oncologists - Hope S. Rugo, MD
  • Development and Regulatory Approval: Focus on Cancer Therapy - Joseph P. Fuhr, Jr., PhD
  • Integrating Biosimilars Into the Treatment of Hematologic Malignancy - Matthew J. Matasar, MD, MS
  • Integrating Biosimilars Into the Treatment of Solid Tumors - Antonio Llombart Cussac, 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/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 enduring educational initiative is directed toward oncology healthcare practitioners based outside of the United States, including medical oncologists, surgical oncologists, radiation oncologists, and pharmacists involved or interested in the treatment of cancers. A broader audience of European pharmacists and physicians are also invited to participate.

Learning Objectives

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

  • Explain the importance of analytical studies in development and regulatory approval of biosimilars
  • Describe the concepts of immunogenicity and extrapolation of indications based on evaluation of the totality of the evidence and mechanism of action rationale
  • Appraise the importance of pharmacoeconomics and access to biological oncology medicines in Europe
  • Discuss the potential clinician-, nurse-, pharmacist-, and patient-specific issues relating to the suboptimal use of biosimilars and strategies to mitigate them
  • Summarize current and emerging data on oncology monoclonal antibody biosimilars and their potential to enable optimal combination therapy

Faculty, Staff, and Planners' Disclosures

Activity Chair

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: Genentech/Roche, Novartis, Merck, Pfizer, OBI, Macrogenics, Lilly, Eisai (for research studies, all funding to UCSF regents)


Joseph P. Fuhr Jr., PhD
Professor Emeritus of Economics, Widener University
Adjunct Professor of Pharmaceutical and Healthcare Business
University of Sciences
Adjunct Faculty at Thomas Jefferson University
College of Population Health
Philadelphia, PA

Disclosure: Honoraria/Consultation Fees: Pfizer, Angen, Sandoz

Antonio Llombart Cussac, MD, PhD
Co-Founder, Medica Scientia Innovation Research (MedSIR ARO)
Chairman, Medical Oncology Service
Hospital Arnau de Vilanova
Valencia, Spain

Disclosure: Grant/Research Support: Pfizer, AstraZeneca, Roche; Honoraria or Consultation Fees: Roche, Eisai, AstraZeneca, Novartis; Stock Shareholder: MedSIR

Matthew J. Matasar, MD
Medical Oncologist
Memorial Sloan Kettering Cancer Center
New York, NY

Disclosure: Grant/Research Support: Genentech, GlaxoSmithKline; Honoraria or Consultation Fees: Genentech, Rocket Pharmaceuticals; Stock Shareholder: Merck

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 focuses on definitions, development, and regulatory approval of biosimilars with a focus on cancer therapy. Below are some highlights from the Live Video Webcast: Advent of Oncology Monoclonal Antibody Biosimilars ‒ A European Perspective Online featuring Drs. Rugo and Fuhr:
  • A biosimilar drug is a “copy” version of an already authorized drug—usually called “originator”—that demonstrates no clinically meaningful differences in terms of quality attributes, efficacy, safety, and immunogenicity compared with an existing licensed, originator biologic:
    • Biosimilars cannot be considered generic equivalents to the originator molecule, and require additional characterization to confirm comparable clinical efficacy and safety.
    • Regulatory framework for the development of biosimilars, first established by the European Medicines Agency (EMA), followed by the World Health Organization (WHO) and the US Food and Drug Administration (FDA), specify the requirements for approval of biosimilars.
    • Important foundational analytical studies are conducted to compare the biosimilar with the approved biologic originator product; comparative nonclinical and clinical studies to assess toxicity and pharmacokinetics (PK)/pharmacodynamics (PD); and clinical studies to demonstrate efficacy, safety, and immunogenicity profiles that are comparable to the originator.
    • One of the core regulatory concepts in the development of biosimilars is extrapolation, which allows for the approval of a biosimilar for use in an indication held by the originator that was not directly studied in clinical trials using the biosimilar.
    • The EMA does not regulate whether a biosimilar is considered interchangeable with the originator because interchangeability is regulated on the national level.
  • Across publicly funded European healthcare systems, a lack of reimbursement may limit access to effective oncology medicines, with reimbursement often contingent upon evidence of cost-effectiveness. Given the approaching patent expiration dates of several biologic anticancer therapies, there has been great interest in developing “biosimilars” to introduce cost savings for healthcare systems, as well as to broaden global access to key biologic therapies.
For additional commentary about these topics and others, visit to access more resources from the archived Live Video Webcast: Advent of Oncology Monoclonal Antibody Biosimilars ‒ A European Perspective Online, including downloadable slides from the webcast.

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