Pfizer Biosimilars Available Speaker Programs

Biosimilars: An Overview for Health Care ProfessionalsThis expert-led, peer-to-peer program will provide health care professionals (HCPs) with an understanding of why biosimilars are being developed and the scientific and clinical considerations used by the US Food and Drug Administration (FDA) to grant them approval.

Attendees will gain an increased knowledge of the types of scientific and clinical data that are required for biosimilar approval by the FDA. This foundation may assist HCPs who choose to incorporate biosimilars into their practice or institution.

Duration: 1 hour

Key Topics:• Background and current state of biologics and biosimilars

• The evolving landscape of biosimilar development in the United States and Europe

• Manufacturing and development of biosimilars

• The requirements and processes by which the FDA evaluates biosimilars for approval

• Extrapolation and designation of interchangeability

A Practical Approach to Biosimilar ImplementationThis expert-led, peer-to-peer program is designed to provide an overview of essential considerations when evaluating biosimilars for formulary inclusion. It also highlights important considerations for the implementation of biosimilars at the HCP’s institution or practice.

Attendees will gain increased understanding of key topics of consideration for biosimilars when deciding to include them on the institution or practice formulary. It is recommended that attendees participate in the Biosimilars Overview Program OR have an understanding of biosimilar and extrapolation regulatory and development concepts as a foundation to build on.

Duration: 1 hour

Key Topics:• Laying the foundation for evaluating a biosimilar

• Biosimilar efficacy and safety: considerations for P&T committees

• Manufacturer, pharmacovigilance, and reimbursement considerations

Beyond Being Biosimilar: A Closer Look at the US FDA Interchangeability Designation, Substitution, and Extrapolation of BiosimilarityThis expert-led, peer-to-peer program will provide HCPs with an in-depth understanding of FDA evaluations (interchangeability designation and extrapolation) after biosimilarity to the reference biologic is established.

Attendees will gain an increased understanding of the difference between the FDA interchangeability designation and a physician-directed switch (single transition) to a biosimilar from the reference biologic. The FDA approach to extrapolation of indications for biosimilars will be explored in detail, along with a practical case study.

Duration: 1 hour

Key Topics:• Summary of biosimilar development and potential benefits

for the health care system

• The FDA interchangeability designation vs physician- directed switching (single transition) to a biosimilar from the reference biologic

• Role of state legislation governing substitution at the pharmacy level of a biosimilar for a reference biologic

• FDA evaluation of extrapolation, including scientific justification that must be provided for each indication not studied clinically with a biosimilar

• A case study illustrating FDA evaluation of extrapolation for a biosimilar

PP-BIO-USA-0360 © 2017 Pfizer Inc. All rights reserved. Printed in USA/April 2017

CME credit is not available for these programs.

For more information or to arrange a speaker program, contact your Pfizer Biosimilars Representative.