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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.

However, while such developments are welcome, further and faster progress could be being made, according to Suzette Kox, secretary general...

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