Fact Sheets

1: Introduction and key definitions

This Fact Sheet provides an introduction to why biological and biosimilar medicines are important, and why IAPO has developed this Information and Advocacy Toolkit on Biological and Biosimilar Medicines. The back of this Fact Sheet provides the reader with key definitions that will be useful while using this Toolkit.

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2: What are biological and biosimilar medicines?

This Fact Sheet provides an overview of what biological and biosimilar medicines are, what they are used for, how they are different to chemical medicines, and how they are produced.

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3: How are biosimilar medicines regulated?

This Fact Sheet provides information about how biosimilar medicines are regulated and why they have a different regulatory process from chemical medicines. It also provides information about the regulatory situation worldwide.

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4: Pharmacovigilance

This Fact Sheet provides information about the monitoring and tracking of medicines once they have been approved in general and specifically in relation to biological and biosimilar medicines. It also provides some key questions for patients’ organizations to consider in relation to pharmacovigilance.

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5: What can patients' organizations do?

This Fact Sheet provides tips on how patients’ organizations can further develop their work on biological and biosimilar medicines, for example through the development of a strategy and action plan.

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