The Australian Therapeutic Goods Administration (TGA) has approved Celltrion’s SteQeyma® (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab). SteQeyma is approved for a 130 mg/26 mL concentrate for solution for infusion vial to treat moderate to severe plaque psoriasis, psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis.
The Australian Pharmaceutical Benefits Assessment Committee (PBAC) will consider SteQeyma® at its November 2024 meeting.
The TGA has previously approved two other ustekinumab biosimilars – Amgen’s Wezlana® (January 2024) and Ajemnye® (May 2024), as well as Janssen’s second brand Setrelvo (July 2024), with the PBAC also recommending Amgen’s Wezlana® for PBS listing at its March 2024 meeting.
Ustekinumab is the subject of ongoing litigation in the Australian Federal Court between Janssen and Samsung Bioepis, with the litigation scheduled for a hearing in March 2025.