Posted by Michael Wonder on 19 Nov 2017
FDA begins adding suffixes to newly approved biologics' names
17 November 2017 - The US FDA this week began adding four-letter meaningless suffixes at the end of newly approved biologics' nonproprietary names, signaling a shift in policy from only adding the suffixes to biosimilars' nonproprietary names since 2015.
The first additions of the meaningless suffixes came for Thursday's approval of Roche's Hemlibra (emicizumab-kxwh), one of the first new medicines in nearly two decades to treat people with hemophilia A, and Wednesday's approval of Ultragenyx Pharmaceutical's Mepsevii (vestronidase alfa-vjbk) to treat pediatric and adult patients with a rare inherited condition called mucopolysaccharidosis type VII, also known as Sly syndrome.
The newly added suffixes were not preceded by an announcement from FDA, though the shift was not entirely unexpected.
