The US Food and Drug Administration’s review of Amgen, Inc.’s Wezlana (ustekinumab-auub), a biosimilar to Janssen Biotech Inc.’s interleukin-12 and -23 antagonist Stelara (ustekinumab), featured a late-in-review pivot toward an interchangeability determination without need for switching study data.
Wezlana Chronology: From Biosimilar To Interchangeable In The Blink Of An Eye
Pink Sheet’s Drug Review Profile looks at the timeline behind the development and FDA review of Amgen’s Wezlana (ustekinumab-auub), an interchangeable biosimilar to Janssen’s Stelara.
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