A Primer on Biosimilars

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Presentation transcript:

A Primer on Biosimilars

Educational Objectives

What Is a Biological Medication?

Differences Between Biosimilars and Generics

Differences Between Biosimilars and Generics (cont)

Differences Between Biosimilars and Generics (cont)

How Are Biologics/Biosimilars Regulated?

FDA Demonstrating Biosimilarity

How Are Biologics/Biosimilars Regulated?

Biologics/Biosimilars Concern Over Immunogenicity

Biosimilars Economic Impact

Biosimilars Challenges / Unresolved Issues

Biosimilars Challenges / Unresolved Issues

Biosimilars From the Pharmacist’s Perspective

Biosimilars Key Take-Home Messages

Abbreviations

References