On 21 October 2024, the Australian TGA approved three presentations of Samsung Bioepis’ Epyztek®, biosimilar to Janssen’s Stelara® (ustekinumab): 90 mg/1 mL solution for injection pre-filled syringe, 45 mg/0.5 mL solution for injection pre-filled syringe and 5 mg/1 mL solution for intravenous infusion injection vial.
The Epyztek® registrations closely follow approvals for two new presentations of Janssen’s second ustekinumab brand, Setrelvo® on 18 October 2024: 90 mg/1 mL solution for injection pre-filled pen (One-Press patient-controlled injector) and 45 mg/0.5 mL solution for injection pre-filled pen (One-Press patient-controlled injector). Setrelvo® was first approved in Australia in July 2024.
Epyztek® is the fourth ustekinumab biosimilar to be approved in Australia, following Celltrion’s SteQeyma®/CT-P43 (September 2024) and Amgen’s Wezlana® (January 2024) and Ajemnye® (May 2024). Australia’s PBAC recommended Wezlana® for PBS listing at its March 2024 meeting.
Samsung Bioepis and Janssen are currently embroiled in two patent infringement and invalidity proceedings in the Federal Court of Australia in respect of patents regarding the use of ustekinumab for the treatment of ulcerative colitis (UC). The first proceeding is expected to be discontinued soon following the surrender of the two innovations patents in suit and the resolution of an outstanding costs issue. The second proceeding has been set down for a 9-day final hearing commencing 2 June 2025.
In the UK, Samsung Bioepis successfully revoked Janssen’s Stelara® UC patent in the High Court of Justice of England and Wales in July 2024. In that case, Mr Justice Meade held that European Patent No EP 3883606 is invalid for obviousness in light of a slide presentation entitled “Safety and efficacy of Ustekinumab Induction Therapy in Patients with Moderate to Severe UC: Results from the Phase 3 UNIFI Study” delivered at the October 2018 American College of Gastroenterology conference. On 26 September 2024, Janssen was refused leave to appeal.