Per a notable squib in BioCentury, the World Health Organization published a draft proposal for a global system to assign "biological qualifiers" to biologics and biosimilars. A biological qualifier is a random four-letter code assigned to a biologic manufactured at a specified site. WHO said the scheme would be voluntary for each regulatory authority and applicable retroactively. The qualifier would not be part of a biologic's international non-proprietary name (INN), although WHO's INN expert group would oversee the scheme. WHO said the proposed scheme is intended to avoid separate national qualifier systems. Comments on the draft are due September 19.
The ill-considered alliance hyping non-differentiated nomenclature for biosimilars gets smaller and more marginalized every day.