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Court Rules Samsung Bioepis Can Sell Private Label Ustekinumab Brands in US

May 1, 2025

On 1 May 2025, Business Korea reported that, on 28 April 2025, Samsung Bioepis defeated Johnson & Johnson (J&J) and Janssen Biotech’s application for a preliminary injunction preventing US sales of the private label version of Samsung Bioepis’ ustekinumab biosimilar.  J&J filed an appeal on 30 April 2025.  Neither the Court’s ruling on the preliminary injunction, nor the appeal filing, are publicly accessible as at 1 May 2025.

Subject to the outcome of the appeal, Samsung Bioepis is now clear to sell private label brands in the US, in addition to Pyzchiva® which Samsung Bioepis has been selling since February 2025.

J&J/Janssen commenced the US action on 24 February 2025, alleging that Samsung Bioepis had breached a settlement and licence agreement entered in July 2023 (announced in November 2023), permitting Samsung Bioepis to launch Pyzchiva® (SB17) (ustekinumab), biosimilar to J&J/Janssen’s Stelara®, in the US from 22 February 2025.  The settlement agreement resolved pending US patent litigation between the companies at the time it was signed.

The complaint, filed the same day on which the US launch of Pyzchiva® was announced, claimed that Samsung Bioepis had entered into an unauthorised sublicence with a private label provider, described in J&J’s complaint as a member of a vertically integrated health conglomerate that includes a health insurer, health care provider, pharmacy chain and pharmacy benefits manager (PBM).  According to J&J, the 2023 settlement agreement did not permit Samsung Bioepis to authorise the private label provider to launch in the US an additional, private label version of biosimilar ustekinumab.

Pyzchiva® was approved by the US FDA in July 2024 for multiple indications, including moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease and ulcerative colitis.  It is commercialised in the US (and Europe and Canada) by Sandoz pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.