FDA reverses course, decides not to add suffixes to older biologics’ nonproprietary names
The FDA has decided not to go back and rename biologics’ nonproprietary names with nonsense suffixes, as it once said it would, raising questions about the confusion that will likely come from a subset of biologics’ and biosimilars’ names containing suffixes while another subset of biologics’ names will not contain suffixes.
Since 2015, the FDA has been adding the meaningless suffixes to biosimilars’ nonproprietary names as part of an effort to improve pharmacovigilance. And since November 2017, the agency also began adding the suffixes to newly approved biologics’ names, with the intention of going back and adding suffixes to all biologics’ nonproprietary names.
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