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Global Harmonization Efforts Must Go Further

IGBA Secretary General Discusses ICH Guidance And Streamlined Biosimilar Pathways

Executive Summary

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.

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Generics Bulletin Editor’s Picks For Q2 2023

Looking back over the second quarter of 2023, Generics Bulletin executive editor Dave Wallace picks out highlights from April to June that include strategic updates from some of the off-patent industry’s biggest players, several exclusive interviews, and the build-up to the second wave of biosimilar competition to Humira in the US.

BsUFA Research Roadmap Highlights Interchangeability And Reducing Trials

The FDA has published a “Research Roadmap” setting out in detail its areas of interest for the agency’s biosimilar regulatory science pilot program under BsUFA III.

Streamlined European Pathway Needed For Biosimilars To Hit Smaller Targets

A more streamlined European regulatory pathway for biosimilars – potentially removing the requirement for confirmatory efficacy trials – is needed for the industry to be able to feasibly offer competition to smaller-value biologic brands, heard delegates to Medicines for Europe’s 18th Biosimilar Medicines Conference.

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