Building Blocks for Biosimilar Integration in Cancer Care
Biosimilar use in oncology is hampered by clinicians’ limited knowledge about biosimilars and concerns about safety and efficacy, including extrapolation, pharmacy-driven substitution, and immunogenicity. This timely educational activity will explain the regulatory framework, how biosimilarity is established, and the rigor of the approval process. By exploring the endpoints and trial designs commonly seen in clinical trials of biosimilars, the faculty will review the concepts of “totality of evidence,” scientific justification for indication extrapolation, and interchangeability.
Learning Objectives
- Describe the regulatory framework and approval pathway for biosimilar products.
- Define “extrapolation” and “interchangeability” and the respective data required in the biosimilar approval process.
- Interpret the endpoints commonly seen in clinical trials of biosimilars compared to those used for reference products.
- Explain the types of clinical trials used for regulatory approval of biosimilars using currently available oncology biosimilars as examples.
Faculty
Sandra Cuellar, Pharm.D., BCOP
Clinical Oncology Pharmacist
University of Illinois Hospital and Health Sciences System
Associate Professor
University of Illinois at Chicago College of Pharmacy
Chicago, Illinois
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Adam Brufsky, M.D., Ph.D.
Professor of Medicine
University of Pittsburgh
Associate Chief
Division of Hematology-Oncology
Pittsburgh, Pennsylvania
Target Audience
This activity was planned to meet the educational needs of physicians, pharmacists, nurse practitioners, and physician assistants caring for oncology patients.
Format
This online activity consists of slide presentations, active learning, an assessment, and evaluation. View the system requirements.
Disclosures
In accordance with ACCME and ACPE Standards for Commercial Support, ASHP policy requires that all faculty, planners, reviewers, staff, and others in a position to control the content of this presentation disclose their financial relationships.
In this activity, only the individuals below have disclosed a relevant financial relationship. No other persons associated with this presentation have disclosed any relevant financial relationships.
- Sandra Cuellar - Speakers bureau for Genentech; advisory board for Coherus Biosciences, Inc.
- Adam Brufsky- Consultant for Amgen, Eisai, Novartis, and Pfizer
Claim CE Within 60 Days
Participants should claim CE credit for this home-study activity only if they have not claimed credit for the live activity.
To receive CE credit, complete the steps below within 60 days of completing the activity.
- View entire presentation and answer all polling questions.
- Click "Complete Activity" on the last slide to complete the assessment and evaluation.
- Verify credits were successfully transferred to CPE Monitor before the ACPE 60-day deadline by checking your NABP eProfile account.
After the 60-day deadline, ASHP will no longer be able to report credit(s).
CPE Information
The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
ACPE #: 0204-000-20-410-H01-P
Release Date: May 19, 2020
Expiration Date: May 19, 2021
Activity Type:
Application-based
CE Credits:
1.0 hour
Activity Fee:
Free of charge
CME Information
The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
The American Society of Health-System Pharmacists designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
