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Positive CHMP Opinion for Amgen’s ustekinumab Biosimilar (Wezenla™)

Apr 25, 2024

On 25 April 2024, EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for Amgen’s Wezenla™ (ustekinumab), biosimilar to Janssen’s Stelara®.   Wezenla™ is proposed to be available in a 45 mg and 90 mg solution for injection, as well as a 130 mg solution for infusion.

Amgen’s Wezlana™ was approved in the US in October 2023, was launched in Canada in March 2024 and was listed on the Australian PBS in January 2024.

CHMP’s positive recommendation for Wezenla™ comes days after Samsung Bioepis’ Pyzchiva® (ustekinumab) was approved in the EU on 25 April 2024.