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.
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US FDA's approval of Ultragenyx's Mepsevii (vestronidase alfa-vjbk) marks first novel biologic with a suffix, but 10 months after release of the naming guidance how – and even how widely – FDA will implement the policy remains uncertain.
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.
The Australian medicines agency has launched a public consultation on whether specific naming requirements should be applied to biologicals and their biosimilar versions. Among the options are the use of bar codes and suffixes to ensure individual products can be identified for traceability and pharmacovigilance purposes.