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Wezlana Chronology: From Biosimilar To Interchangeable In The Blink Of An Eye

 
• By Sue Sutter

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.

Drug Review Profile: Wezlana
• Source: Shutterstock

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.

In September 2023, the FDA shared its updated scientific thinking that switching studies were not necessary for ustekinumab biosimilars to obtain an interchangeability designation. This led Amgen to request the designation for its two applications in the last month of their review

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