On 5 August 2025, CivicaScript, LLC announced that it will distribute Fresenius Kabi’s unbranded ustekinumab-aauz, biosimilar to J&J/Janssen’s Stelara®, in the US from 1 January 2026. CivicaScript is a nonprofit company dedicated to bringing low-cost generic medicines to US patients, and will be the exclusive distributor of Fresenius Kabi’s unbranded ustekinumab-aauz.
Fresenius Kabi has already launched its branded ustekinumab biosimilar, Otulfi®, in the US in March 2025 and in Canada in May 2025. Otulfi® was developed by Formycon and was approved in the US and Europe in September 2024 and in Canada and the UK in January 2025. It is being commercialised in Canada, the US, and most of Europe by Fresenius Kabi under a global licence agreement entered into between Formycon and Fresenius in February 2023. Under the agreement, Fresenius has exclusive commercialisation rights to the ustekinumab biosimilar in key global markets, while Formycon retains semi-exclusive commercialisation rights in Germany, parts of the MENA region and Latin America.
In August 2023, Formycon and Fresenius reached a settlement with J&J in the US, enabling US launch of FYB202 “no later than 15 April 2025” (the biosimilar’s US launch was in early March 2025). This was followed by a settlement in March 2024 regarding the commercialisation of FYB202/Otulfi® in Europe and Canada, with the launch dates in those countries previously undisclosed.