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Amgen’s Ustekinumab Biosimilar First to Launch in US; Available Through Nuvaila

Jan 16, 2025

On 16 January 2025, AIS Health reported that Amgen has launched Wezlana® (ustekinumab), biosimilar to J&J/Janssen’s Stelara® in the US through Optum Health Solution’s private label subsidiary Nuvaila.  The biosimilar is said to have been launched on 1 January 2025 and is available in both intravenous and subcutaneous forms for all indications of Stelara®.

Wezlana® was the first interchangeable ustekinumab biosimilar approved by the FDA in October 2023.  It was launched in Canada in March 2024 and has been approved in Europe (June 2024, as WezenlaTM) and approved (January 2024) and PBS-listed (April 2024) in Australia.