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.