regulatoryinnovation
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Description

Biosimilar medicines provide an opportunity to increase competition for biologic medicines that have lost exclusivity, thus improving patient access to existing and innovative treatment, increasing physician treatment choice and generating savings for health systems. Most active substances in biological medicines are proteins. They can differ in size and complexity and can have a degree of variability in the molecules of the same active substance. Therefore, the traditional approaches to developing generic medicines are not appropriate.
In the EU a regulatory pathway for approving biosimilar medicines has been in place since 2003, followed by US pathways. Developers of biosimilars must demonstrate through comprehensive studies with the 'reference' biologic. Some of the challenges continue beyond market approval. This session explores how other world regions approach biosimilars.

Ability Level: All

Session ID: 20996

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