On 27 May 2025, Bio-Thera Solutions and Hikma Pharmaceuticals announced that the US FDA has approved BAT2206, marketed as Starjemza® (ustekinumab-hmny), biosimilar to J&J/Janssen’s Stelara® (ustekinumab).
The approval of Starjemza® follows six ustekinumab biosimilars already launched in the US: Amgen’s Wezlana® (Jan 2025), Alvotech/Teva’s Selarsdi® (Feb 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (Feb 2025), Biocon’s Yesintek® (Feb 2025), Formycon/Fresenius Kabi’s Otulfi® (Mar 2025) and Celltrion’s Steqeyma® (Mar 2025).
Bio-Thera and Hikma signed an exclusive commercialisation and licence agreement in relation to BAT2206/Starjemza® in August 2021. Under the agreement, Hikma has exclusive commercialisation rights in the US while Bio-Thera remains responsible for the development and manufacturing of the product.
Bio-Thera also has commercialisation and licence agreements for BAT2206/Starjemza® with Gedeon Richter for the EU, UK, Switzerland and selected other countries (entered October 2024), Dr Reddy’s for certain Southeast Asian countries including Cambodia, Indonesia, Malaysia, Philippines, Thailand and Vietnam (entered March 2025), World Medicine for Turkey (entered January 2025), and Tabuk Pharmaceuticals for Saudi Arabia (entered December 2024).