On 6 November 2025, Hikma Pharmaceuticals announced its US launch of Starjemza™, biosimilar to J&J/Janssen’s Stelara® (ustekinumab). This is the first biosimilar Hikma has launched in the US.
Starjemza™ was approved by the FDA in May 2025. It is commercialised in the US by Hikma under an exclusive commercialisation and licence agreement with Bio-Thera entered in August 2021. Bio-Thera remains responsible for the development and manufacture of the product.
Other ustekinumab biosimilars launched in the US to date are: Amgen’s Wezlana® (January 2025), Alvotech/Teva’s Selarsdi® (February 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (February 2025), Biocon’s Yesintek® (February 2025), Formycon/Fresenius Kabi’s Otulfi® (March 2025) and Celltrion’s Steqeyma® (March 2025).