Two BLAs, One Suffix: FDA Diverges From Nonproprietary Naming Guidance For Amgen’s Wezlana

Assigning different suffixes to the prefilled syringe and intravenous formulations of Amgen’s ustekinumab biosimilar could create confusion and would not further the goals of the naming convention, the FDA said in explaining why it departed from its January 2017 final guidance.