Novel Biologics Will Get Suffixes (Or At Least One Did)
Executive Summary
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.
You may also be interested in...
Policy Reversal: FDA Will No Longer Require Suffixes For Older Biologics
New US FDA draft guidance says that the agency will no longer change the proper names of originator biologics to include a four-letter suffix, although the agency will continue to attach suffixes to future approvals.
Biosimilar Suffixes Appear Superfluous In Adverse Event Reporting
Nearly all adverse event reports received by US FDA include brand name of biosimilar, raising questions as to whether suffix on nonproprietary name is necessary for pharmacovigilance.
Biosimilar Suffixes Appear Superfluous In Adverse Event Reporting
Nearly all adverse event reports received by US FDA include brand name of biosimilar, raising questions as to whether suffix on nonproprietary name is necessary for pharmacovigilance.