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