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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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.
EMA-HMA Biosimilar Interchangeability Statement Offers ‘Unity And Clarity’ For Europe
The recent statement by the EMA and HMA affirming the interchangeability of biologics and biosimilars has given a boost to Europe’s biosimilars industry ahead of key legislative reforms, heard delegates to Medicines for Europe’s 18th Biosimilar Medicines Conference in Brussels.