On 18 August 2025, MedImpact Holdings Inc. announced that, from 1 January 2026, Teva subsidiary Anda’s unbranded ustekinumab-aekn (biosimilar to J&J/Janssen’s Stelara®) will be available for direct purchase from MedImpact’s preferred partner, Birdi, Inc., by any licensed specialty pharmacy.
Separately, CivicaScript announced earlier this month that it will distribute Fresenius Kabi’s unbranded ustekinumab-aauz in the US from 1 January 2026.
MedImpact’s announcement follows Alvotech’s and Teva’s announcement in May 2025 that the FDA had approved Selarsdi® as interchangeable with Stelara® in all presentations, including for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis.
Selarsdi® was the second ustekinumab biosimilar launched in the US, in February 2025, following a settlement between Alvotech/Teva and J&J entered in June 2023, which permitted the US launch of the biosimilar from 21 February 2025. Other ustekinumab biosimilars that have been launched in the US to date are: Amgen’s Wezlana® (January 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (February 2025), Biocon’s Yesintek® (February 2025), Formycon/Fresenius Kabi’s Otulfi® (March 2025) and Celltrion’s Steqeyma® (March 2025).
Selarsdi® was developed by Alvotech and is commercialised by Teva in the US, pursuant to an August 2020 strategic partnership between the companies for the exclusive commercialisation of five of Alvotech’s biosimilar product candidates. The partnership was expanded in July 2023 to include four additional products.