WHO proposes 'biological qualifier' system for biosimilars

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. ...