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Biosimilars: US FDA’s Updated Scientific Thinking Led To Interchangeability For Amgen's Wezlana

 
• By Sue Sutter

Pink Sheet’s Drug Review Profile explores Amgen’s Wezlana, an interchangeable biosimilar to Janssen’s Stelara. FDA determined late in the review that switching studies generally would not be needed for interchangeable ustekinumab products, prompting Amgen to seek the designation.

Drug Review Profile: Wezlana
Wezlana is approved for all the same indications as Stelara. • Source: Shutterstock

A change in the US Food and Drug Administration’s scientific thinking led Amgen, Inc. to request an interchangeability designation for Wezlana, a biosimilar of Janssen Biotech Inc.’s Stelara (ustekinumab), in the last month of the product’s regulatory review.

With plans to seek initial approval of Wezlana (ustekinumab-auub) only as a biosimilar, Amgen’s biologics license applications did not include results from a switching study intended to support an interchangeability designation

Key Takeaways

  • Late in the review of Amgen’s Wezlana, the FDA said switching studies would not be considered necessary for biosimilar ustekinumab products to receive an interchangeability designation.

  • Amgen requested the interchangeable designation with less than a month to go in the review process.

  • Wezlana is the seventh interchangeable biosimilar approved by the FDA, and the fifth one in the absence of switching study data

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