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LEARNING ABOUT
BIOSIMILARS
What is a biosimilar?
Biosimilar versus generics
Biosimilar development and approval processes
Biosimilar dispensing
Extrapolation
Are long-available reference products “biosimilars” of their approved versions?
INTERCHANGEABILITY
-DESIGNATION MATTERS
What is interchangeability?
What does it take to be for a biosimilar to be designated interchangeable?
What are the benefits of a biosimilar receiving interchangeability designation?
Understanding the difference between switching, substitution, and interchangeability
VALUE OF
BIOSIMILARS
Why biosimilars?
Reducing costs
Expanding access
Uptake of biosimilars in the US
EDUCATIONAL
RESOURCES
NEWS &
EVENTS
ABOUT
US
LEARNING ABOUT BIOSIMILARS
INTERCHANGEABILITY – DESIGNATION MATTERS
VALUE OF BIOSIMILARS
EDUCATIONAL RESOURCES
NEWS & EVENTS
ABOUT US
Educational Resources
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2019-04-22T14:36:12+00:00
EDUCATIONAL RESOURCES
U.S. Food and Drug Administration: Biosimilars Web page
Biosimilars Resources Center
Generics and Biosimilars Initiative
The Biosimilars Council
The Center for Biosimilars
American College of Rheumatology: The Science Behind Biosimilars: Entering a New Era of Biologic Therapy
The New England Journal of Medicine: Friction in the Path to Use of Biosimilar Drugs
American Society of Clinical Oncology Statement: Biosimilars in Oncology
White Paper: Structural Market Changes Needed in U.S. to Achieve Cost-Savings from Biosimilars Lessons from Europe’s Biosimilars Successes
