On 5 May 2025, Alvotech and Teva announced that the US FDA has approved Selarsdi® (ustekinumab-aekn) as interchangeable with J&J’s Stelara® (ustekinumab) in all presentations, including for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis.
According to an Alvotech/Teva announcement in February 2025, the FDA had granted Selarsdi® a provisional determination of interchangeability to commence after the expiry of exclusivity for Amgen’s Wezlana® (the first ustekinumab biosimilar to be approved as interchangeable in the US) on 30 April 2025. Wezlana® and Selarsdi® are the only ustekinumab biosimilars currently approved by the FDA as interchangeable with Stelara®.
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. Four other ustekinumab biosimilars have also been launched in the US to date: Samsung Bioepis/Sandoz’s Pyzchiva® (Feb 2025), Biocon’s Yesintek® (Feb 2025), Formycon/Fresenius Kabi’s Otulfi® (Mar 2025) and Celltrion’s Steqeyma® (Mar 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.