WHO Still Planning Biosimilar Naming Guidance, Gives Update On Prequalification Pilot
Despite putting it on hold last year, the World Health Organization is keeping its idea of biosimilar naming guidance alive. And at a recent conference it updated delegates on the pilot project for prequalifying biosimilar versions of infliximab and trastuzumab.
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Canada Wants Views On Three Options For Naming Of Biologic Drugs
In the absence of an international convention on the naming of biological medicines, the Canadian regulator is looking at various options before it decides on a formal approach to distinguish between biologic drugs that have the same non-proprietary name. It wants to adopt an approach that allows accurate identification, is compatible with existing drug information systems and databases, and is easy to implement.
Biologics Naming: US FDA Ponders How To Put New System In Place, While WHO Puts Hold On Pilot Study
US regulator is currently focused on prospective application of suffix-based naming system for most novel biologics and biosimilars but is still considering how best to change the names of existing products. Meanwhile, World Health Organizations announces it will not proceed 'at present' with its biological qualifier program.
ICH Expansion Prompts WHO To Review Definition Of 'Stringent Regulatory Authorities'
European research-based pharmaceutical industry association, EFPIA, says it "makes sense" for the World Health Organization to review the concept of "stringent regulatory authorities," which is linked to a country's membership of the International Council for Harmonisation.