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Global Harmonization Efforts Must Go Further

IGBA Secretary General Discusses ICH Guidance And Streamlined Biosimilar Pathways

 
• By Dave Wallace

With global regulation of off-patent medicines continuing to evolve, IGBA secretary general Suzette Kox talks about the progress expected from regulatory harmonization for generics and a reduced clinical trial burden for biosimilars.

Harmonize word in dictionary
Harmonization efforts are under way for generics and biosimilars • Source: Shutterstock

As global harmonization efforts on regulatory approaches to generic medicines continue to move forwards, the international off-patent industry has also seen recent pushes for international regulators to adopt a more streamlined approach to registering biosimilars, potentially allowing for a reduced clinical trial and data burden as stakeholders become more comfortable with using analytical tools to evaluate biosimilarity.

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