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Approval Alert: Celltrion’s Ustekinumab Biosimilar Receives South Korean Approval

Jun 13, 2024

On 13 June 2024, the Korea Herald reported that Celltrion’s Steqeyma (CT-P43), biosimilar to J&J’s Stelara® (ustekinumab), has been approved by the South Korean Ministry of Food and Drug Safety for all indications of Stelara®.  No launch date has been announced.   

Celltrion is also seeking approval for Steqeyma in Europe, the United States, and Australia.  The company submitted applications with the EMA in May 2023, the FDA in June 2023, and the TGA in April 2023.   

Over the last 9 months, a number of ustekinumab biosimilars have been launched, approved or recommended for approval: 

  • Amgen’s Wezlana® – approved in US (October 2023) and Australia (January 2024, and  PBS listed in April 2024), launched in Canada (March 2024), and received a positive recommendation from EMA’s CHMP (April 2024); 
  • Alvotech’s AVTO4 – approved in US (as Selarsdi®, with Teva, April 2024), Europe (as Uzpruvo®, with STADA, January 2024) and Japan (with Fuji Pharma, September 2023), and launched in Canada (as Jamteki®, with JAMP Pharma, March 2024); and 
  • Samsung Bioepis’ SB17 – approved in Europe and Korea (as Pyzchiva® and EpyztekTM, respectively, April 2024).  Samsung Bioepis is challenging two of Janssen’s Stelara® (ustekinumab) Australian patents in the Australian Federal Court. The trial is provisionally scheduled for November 2024.