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From Biologics to Biosimilars in Oncology Practice: A New Source of Value

  • Authors: Jeffrey Crawford, MD; Gary H. Lyman, MD, MPH, FASCO, FRCP, FACP
  • CME Released: 12/22/2017
  • Valid for credit through: 12/22/2018
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Target Audience and Goal Statement

This activity is intended for medical oncologists, hematologists, nurses, pharmacists, and other clinicians involved in the care of patients with cancer.

To date, 8 biosimilars have been approved by the FDA, and more are expected to be approved as a means of controlling rising medical costs. To be approved, a biosimilar must show "no clinically meaningful differences" to the approved biologic with the same mechanism of action, route of administration, dosage form, strength, and indications as the reference biologic. In addition, "interchangeable" biologics are biosimilars that have demonstrated similar efficacy in patients and can be automatically substituted for branded biologics.

However, many physicians have lingering concerns about safety, efficacy, formulations, and formularies with biosimilars. "From Biologics to Biosimilars in Oncology Practice" will review the documentation process of biosimilars and provide comparisons of evidence between biosimilars and their reference biologics. The activity will also cover cost-comparison scenarios, review the development and approval process, and explore factors that are likely to impact the assimilation of biosimilars into the treatment paradigm.

Upon completion of this activity, participants will be able to:

  1. Understand the differences between biosimilar and generic products and between biosimilar and originator biologic therapies, including clinical data (ie, pharmacodynamics and safety) needed for biosimilar approvals compared to originator biologics
  2. Mitigate potential clinical barriers to the adoption of biosimilar agents in community cancer centers
  3. Discuss administrative and cost barriers to biosimilar implementation, including impediments to healthcare coverage and reimbursement


Potomac Center for Medical Education (PCME) adheres to the policies and guidelines, including the Standards for Commercial Support, set forth to providers by the Accreditation Council for Continuing Medical Education (ACCME) and all other professional organizations, as applicable, stating those activities where continuing education credits are awarded must be balanced, independent, objective, and scientifically rigorous.

All persons in a position to control the content of a continuing medical education program provided by PCME are required to disclose any relevant financial relationships with any commercial interest to PCME as well as to learners. All conflicts of interest are identified and resolved by PCME in accordance with the Standards for Commercial Support in advance of delivery of the activity to learners. The content of this activity was vetted by an external reviewer to assure objectivity and that the activity is free of commercial bias.

The contents of some CME/CE activities may contain discussions of non-approved or off-label uses of some agents mentioned. Please consult the prescribing information for full disclosure of approved uses.


  • Jeffrey Crawford, MD

    George Barth Geller Professor for Research in Cancer, Co-Program Leader, Solid Tumor Therapeutics Program, Duke Cancer Institute, Durham, North Carolina


    Consultant/Independent Contractor: AstraZeneca, Merck, Pfizer; Grant/Research Support: Amgen, AstraZeneca, Bayer; Chair/Member: BeyondSpring, Celgene, G1 Therapeutics, Janssen, Merrimack, Mylan, Roche.

  • Gary H. Lyman, MD, MPH, FASCO, FRCP, FACP

    Co-Director, Hutchinson Institute for Cancer Outcomes Research, Public Health Sciences Division and Clinical Research Divisions, Fred Hutchinson Cancer Research Center, Professor of Medicine, University of Washington School of Medicine, Seattle, Washington


    Consultant/Independent Contractor: G1 Therapeutics, Halozyme; Grant/Research Support: Amgen.

    Chad Williamson; Blair St. Amand; Lindsay Scott, PT, DPT, ATC: Nothing to disclose.

Accreditation Statements

    For Physicians

  • Jointly provided by the Potomac Center for Medical Education and Rockpointe Oncology.

    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 the Potomac Center for Medical Education and Rockpointe Oncology. The Potomac Center for Medical Education is accredited by the ACCME to provide continuing medical education for physicians.

    The Potomac Center for Medical Education designates this enduring material for a maximum of 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    Contact This Provider

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]

Instructions for Participation and Credit

There are no fees for participating in or receiving credit for this online educational activity. For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 67% on the post-test.

Follow these steps to earn CME/CE credit*:

  1. Read the target audience, learning objectives, and author disclosures.
  2. Study the educational content online or printed out.
  3. Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test. In addition, you must complete the Activity Evaluation to provide feedback for future programming.

You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates from the CME/CE Tracker.

*The credit that you receive is based on your user profile.


From Biologics to Biosimilars in Oncology Practice: A New Source of Value

Authors: Jeffrey Crawford, MD; Gary H. Lyman, MD, MPH, FASCO, FRCP, FACPFaculty and Disclosures

CME Released: 12/22/2017

Valid for credit through: 12/22/2018


Before you begin, please answer the questions in this brief questionnaire.

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