On 12 July 2023, Samsung Bioepis UK Limited commenced proceedings against Janssen Biotech Inc in the High Court of Justice of England and Wales seeking to invalidate the UK counterpart patent of European Patent No. EP 3 883 606. Janssen’s patent relates to the use of ustekinumab for the treatment of ulcerative colitis and Janssen counter-claimed against Samsung Bioepis for patent infringement. Mr Justice Meade heard the case on 24-26 June and 1-2 July 2024. Judgment is expected within the next few months.
Samsung Bioepis’ ustekinumab biosimilar (SB17) was approved in Europe in April 2024 as Pyzchiva®. Pyzchiva® will be commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.
Samsung Bioepis is also currently challenging two of Janssen’s Stelara® (ustekinumab) Australian patents in the Australian Federal Court, with a trial provisionally scheduled for November 2024.
On 1 July 2024, Samsung Bioepis announced that the FDA approved its Pyzchiva® (SB17) for multiple indications, including moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease and ulcerative colitis. The FDA has provisionally determined Pyzchiva® as interchangeable with Stelara®. Samsung Bioepis is licensed to launch Pyzchiva® in the US in Q2 2025, under a settlement and licence agreement with J&J entered in November 2023 resolving US litigation between the companies.