Insights on Developing and Evaluating Biosimilars for Cancer Care
  • CME
  • CE

How do biosimilars compare with reference biologics and small-molecule compounds? Here’s my take.
Rowena N. Schwartz, PharmD, BCOP
Physicians: maximum of 0.25 AMA PRA Category 1 Credits
Registered Nurses: 0.2 Nursing contact hours
Pharmacists: 0.25 contact hours (0.03 CEUs)
Released: November 14, 2018 Expiration: November 13, 2019

Learning Objectives

Upon completion of this activity, participants should be able to:
  • Describe differences between biosimilars and reference biologics in terms of their structure, function, regulatory requirements, and data demonstrating biosimilarity

Acknowledgements

Provided by Postgraduate Institute for Medicine
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Postgraduate Institute for Medicine
304 Inverness Way South, Suite 100
Englewood, CO 80112

Allison Hughes, CCMEP, Program Manager
(303) 799-1930
(303) 858-8842 (Fax)
ahughes@pimed.com
www.pimed.com

This activity is supported by an educational funding donation provided by
Amgen

Information on this Educational Activity

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity:

Faculty

Rowena N. Schwartz, PharmD, BCOP

Associate Professor
University of Cincinnati
Cincinnati, Ohio

Rowena N. Schwartz, PharmD, BCOP, has disclosed that she has received consulting fees from Heron Therapeutics.

Staff

Megan K. Murphy, PhD

Clinical Editor

Megan K. Murphy, PhD, has no real or apparent conflicts of interest to report.
Ashley Bohn, PhD, MS, RVT

Clinical Editor

Ashley Bohn, PhD, MS, RVT, has disclosed that she has received fees for non-CME/CE services from Lilly and Merck.
Timothy A. Quill, PhD

Associate Editorial Director, Oncology

Timothy A. Quill, PhD, has no real or apparent conflicts of interest to report.

The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity:

The PIM planners and managers have nothing to disclose.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners.  Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Target Audience

This program is intended for physicians, physician assistants, nurse practitioners, registered nurses, and pharmacists who care for patients with cancer who are candidates for biosimilar agents.

Goal

The goal of this activity is to improve participants’ competence in applying the latest practice-changing data in the individualized clinical management of patients with cancer who are candidates for treatment with biologic agents.

Physician Continuing Medical Education

Joint Accreditation Statement
In support of improving patient care, Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

The Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nursing Continuing Education

Credit Designation

The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hour.

Pharmacist Continuing Education

Credit Designation

Postgraduate Institute for Medicine designates this continuing education activity for 0.25 contact hour (0.025 CEUs) of the Accreditation Council for Pharmacy Education. Universal Activity Number - JA4008162-0000-18-440-H01-P.

Type of Activity: Knowledge

Program Medium

This program has been made available online.

Instructions for Credit

Participation in this self-study activity should be completed in approximately 0.25 hours. To successfully complete this activity and receive credit, participants must follow these steps during the period from November 14, 2018, through November 13, 2019:

1. Register online at http://www.clinicaloptions.com.
2. Read the target audience, learning objectives, and faculty disclosures.
3. Study the educational activity online or printed out.
4. Submit answers to the posttest questions and evaluation questions online.

You must receive a test score of at least 100% and respond to all evaluation questions to receive a certificate. After submitting the evaluation, you may access your online certificate by selecting the certificate link on the posttest confirmation page. Records of all CME activities completed can be found on the "CME Manager" page. There are no costs/fees for this activity.

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