Global Harmonization Efforts Must Go Further
IGBA Secretary General Discusses ICH Guidance And Streamlined Biosimilar Pathways
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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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.
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.
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.