Biosimilars: A New Era of Hematology/Oncology Management Considerations

With the increasing entry of biosimilars into clinical practice it is important to equip and prepare hematology/oncology clinicians with information that can provide a context for the appropriate use of biosimilars. This program looks to increase clinician awareness, knowledge, and confidence regarding the role of biosimilars in clinical care, which has the potential for a notably positive impact on patient access to biologic therapy, as well as cost of care.


This two-part, audio-guided online course presents practical, foundational information on biosimilars, while also addressing issues and barriers most commonly encountered in the clinical setting.

Learning Objectives

  • Define biosimilars, extrapolation, and interchangeability on the basis of FDA definitions and guidance
  • Explain the basics of the FDA approval process and how it uses the “totality of evidence” to determine biosimilarity
  • Explore data on safety and immunogenicity of originator biologics and biosimilars
  • Examine relevant regulations concerning pharmacy substitution with biosimilars
  • Apply the foundational knowledge on biosimilars into clinical situations relevant to hematology/oncology practice

Target Audience

Hematologists, hematologist/oncologists, oncologists, and others who are managing patients with neoplasms and need to stay updated on developments related to biosimilars.

Faculty Disclosures

Jeffrey Crawford, MD
Duke University Medical Center, Durham, NC
Research Funding: Amgen; Astra Zeneca; Bayer;
Membership on a Board or Advisory Committee: Astra Zeneca; Beyond Spring; Celgene; G1 Therapeutics; Janssen; Merck; Merrimack; Mylan; Pfizer; Roche;

Gary H. Lyman, MD, MPH
Fred Hutchinson Cancer Research Center, Seattle, WA
Consultancy: Halozyme;
Research Funding: Amgen;
Honoraria: Coherus;
Speakers Bureau: Amgen;
Membership on a Board or Advisory Committee: G1 Therapeutics;

Andrew D. Zelenetz, MD, PhD
Memorial Sloan-Kettering Cancer Center, New York, NY
Consultancy: Amgen; Astra Zeneca; Celgene; Gilead; Hospira; Pharmacyclics; Roche/Genentech; Sandoz; Takeda;
Research Funding: Genentech; Roche;
Honoraria: Takeda;
Membership on a Board or Advisory Committee: Adaptive Biotechnologies Corp; Beigene; Boehringer Ingelheim; Cancer Genetics; Celgene; Gilead; NanoString; Novartis; Portola Pharmaceuticals; Roche; Roche/Genentech;


Date of release

December 4, 2017

Date of expiration

Online access expiration and last date for learners to claim CME/MOC credit for this course: December 3, 2018

Accreditation and Credit Designation

The American Society of Hematology (ASH) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education (CME) for physicians.

ASH designates this internet enduring material for a maximum of 3.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Physicians who participate in this CME activity but are not licensed in the United States are also eligible for AMA PRA Category 1 Credit™.

ABIM Maintenance of Certification Points

Successful completion of this CME activity enables the participant to earn up to 0.5 Maintenance of Certification (MOC) points in the ABIM MOC program. Participants earn MOC points equivalent to the amount of CME credits claimed for the activity.

It is the CME activity provider’s responsibility to submit participant completion information to the Accreditation Council for Continuing Medical Education (ACCME) for the purpose of granting ABIM MOC credit.

Claiming CME and ABIM Credit

The estimated time to complete this educational activity, comprised of 7 webinars, is 3.50 hours. To claim CME credit, learners must complete the post-test(s) of medical knowledge and an activity evaluation for each Biosimilars webinar viewed. Evaluation modules can be accessed upon completion of corresponding webinars.

Learners who pass the post-tests are eligible to claim credit for the activity. The learner is allowed multiple attempts to pass the post-test for each Biosimilars webinar. Successful completion of each test earns the learner a portion of the total 3.5 credit hours. Learners claim CME and/or MOC credit for each test individually.

Biosimilars: A New Era of Hematology/Oncology Management Considerations

Credit Hours

Part I: What Do You Know?

1. Why Biosimilars, Why Now? 0.5
2. Biologics, Manufacturing Process Changes, and Biosimilars 0.5
3. FDA Criteria for Biosimilar Approval 0.5
4. Interchangeability and Pharmacy-Level Substitution 0.5

Part II: What Would You Do?

5. Patient with Newly Diagnosed Diffuse Large B-Cell Non-Hodgkin Lymphoma: Considering Biosimilars 0.5
6. Patients with Lymphoma: Switching to a Biosimilar? 0.5
7. Patient with Relapsed Large Cell Lymphoma: Reference Product or Biosimilar? 0.5

Total Credit Hours

3.5

On December 3, 2018, online access expires. This is also the last date for users to claim credit for this activity.

For questions about credit, please contact the ASH Education Department at cme@hematology.org or call toll-free 866-828-1231 (within the United States only).


Part I: What Do You Know?

Experts define and present key didactic information to provide practical, foundational information on biosimilars.

1. Why Biosimilars, Why Now?

CME
MOC
In this webinar, Dr. Gary Lyman provides background information on biosimilars, including the link between rising health care costs and the development of biosimilars. Anticipated benefits of biosimilars are also reviewed.

2. Biologics, Manufacturing Process Changes, and Biosimilars

CME
MOC
The process for the evaluation of a biosimilar is fundamentally the same as the evaluation of manufacturing process changes for reference biologics. In this webinar, Dr. Andrew Zelenetz discusses this context for the comparability exercise for biosimilars.

3. FDA Criteria for Biosimilar Approval

CME
MOC
In this webinar, Dr. Jeffrey Crawford presents the U.S. Food and Drug Administration (FDA) approval process for biosimilars, including the step-wise, “totality of evidence” approach.

4. Interchangeability and Pharmacy-Level Substitution

CME
MOC
In this webinar, Dr. Gary Lyman answers your questions about interchangeability and pharmacy-level substitution with biosimilars. He also provides information on how to find the status of state laws impacting practice in your location.
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Part II: What Would You Do?

Learners interpret the foundational information about biosimilars through the evaluation of three case-based scenarios

5. Patient With Newly Diagnosed Diffuse Large B-Cell Non-Hodgkin Lymphoma: Considering Biosimilars

CME
MOC
Drs. Jeffrey Crawford and Gary Lyman discuss the data and considerations that inform the potential use of biosimilars in a patient with newly diagnosed non-Hodgkin lymphoma.

6. Patients With Lymphoma: Switching to a Biosimilar?

CME
MOC
Drs. Andrew Zelenetz and Jeffrey Crawford discuss two different cases and review the data and considerations for switching from a reference biologic to a biosimilar.

7. Patient With Relapsed Large Cell Lymphoma: Reference Product or Biosimilar?

CME
MOC
In this webinar, Drs. Andrew Zelenetz and Gary Lyman review clinical trial data and discuss extrapolation as it relates to the potential use of a biosimilar in a patient with relapsed large cell lymphoma.
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