On 14 April 2026, the US Court of Appeals for the Third Circuit published its judgment confirming the District Court’s decision to refuse to grant a preliminary injunction to prevent Samsung Bioepis from supplying its biosimilar ustekinumab to Cigna’s Quallent.
The decision arises from a complaint filed by Johnson & Johnson/Janssen in the US District Court for the District of New Jersey on 24 February 2025 alleging that Samsung Bioepis had breached a settlement and licence agreement entered in July 2023 (announced in November 2023). The agreement permitted Samsung Bioepis to launch Pyzchiva®/SB17 (ustekinumab), biosimilar to J&J/Janssen’s Stelara®, in the US from 22 February 2025. In November 2024, Samsung Bioepis entered into a Private Label Distributor (PLD) Agreement with Quallent Pharmaceuticals Health LLC, a subsidiary of the Cigna Group. J&J/Janssen alleged that the sublicence to Quallent breached the settlement agreement and Janssen filed a motion for a preliminary injunction to prevent Samsung from supplying Quallent or authorising Quallent to distribute SB17 while the litigation was pending.
The US District Court refused to grant a preliminary injunction on the basis that Janssen had failed to establish that it would suffer irreparable harm if the injunction was not granted. The Appeals Court found no error in that decision. J&J/Janssen’s underlying breach of contract case remains ongoing.
Pyzchiva® was launched in the US by Sandoz in February 2025 (in PFS and vial forms), under a September 2023 development and commercialisation agreement with Samsung Bioepis. That agreement gives Sandoz the right to commercialise Pyzchiva® in the US, as well as Europe, Switzerland, the UK and Brazil. Pyzchiva® was launched in Europe in July 2024 and a Pyzchiva® autoinjector was launched in May 2025 as the first commercially available biosimilar ustekinumab pre-filled pen in Europe.
J&J has previously entered into ustekinumab settlement agreements with Amgen (which launched its biosimilar, Wezlana®, in the US in early January 2025 through Optum Health Solution’s private label subsidiary Nuvaila), Alvotech and Teva (Selarsdi® launched on 21 February 2025), Biocon (Yesintek™ launched on 24 February 2025), Celltrion (Steqeyma® launched March 2025), and Fresenius Kabi and Formycon (Otulfi® launched March 2025). Other ustekinumab biosimilars launched in the US include Dong A-ST/Accord’s Imuldosa® (launched August 2025) and Bio-Thera/Hikma’s Starjemza™ (launched November 2025).