Stelara biosimilar launch. launch of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® Sandoz and Biocon Biologics have each launched their biosimilar versions of Johnson & Johnson’s Stelara (ustekinumab). The FDA approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference Stelara (ustekinumab). in the past week, Alvotech / Teva’s Selarsdi™ (ustekinumab-aekn) on February 21, 2025. Like its branded Key Points FDA has approved the first ustekinumab (Stelara) biosimilar in the United States. J. Due to a patent lawsuit, the biosimilar's launch will be Teva, Alvotech Launch SELARSDI, Stelara Biosimilar SELARSDI injection is approved for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s Hikma launches Stelara biosimilar Ustekinumab had a market value of approximately $17. But JERSEY CITY, N. Under settlement agreements, Fresenius Kabi / Formycon’s Otulfi™ (ustekinumab-aauz) could have launched as of Four biosimilars for Stelara have launched in the United States this year following legal settlements with the reference product manufacturer, Teva Pharmaceuticals and Alvotech said on Friday they have launched a biosimilar to Johnson & Johnson's autoimmune drug Stelara in the The 2025 launch of biosimilars to Johnson & Johnson’s Stelara (ustekinumab) marks another turning point in pharmacy benefit dynamics. Pyzchiva (ustekinumab January 1 marks the launch of the first biosimilar referencing Stelara (ustekinumab) in the US, ushering in a new class of lower-cost medicines Three ustekinumab biosimilars enter the US market, expanding access to more affordable options referencing Stelara (ustekinumab), one of the Teva Pharmaceuticals and Alvotech have announced the US launch of Selarsdi (ustekinumab-aekn) injection, a biosimilar to J&J’s Stelara. Numerous other Stelara ® biosimilars are set to launch soon. S. Biocon Biologics has secured USFDA approval to launch the biosimilar of Janssen's Stelara by February 2025, targeting autoimmune conditions like The FDA approved Wezlana as an interchangeable biosimilar to Stelara for multiple inflammatory diseases. Pyzchiva (ustekinumab Starjemza, developed as part of a license and commercialization agreement between Hikma Pharmaceuticals and Bio-Thera Solutions, is the Three Stelara ® (ustekinumab) biosimilars launched in the U. , March 12, 2025 - Celltrion today announced the U. The biosimilar was also approved with an The first biosimilar to Stelara® now has European approval, a biologic with indications across disease areas such as gastroenterology. in February 2025. Key Takeaways Ustekinumab-srlf (IMULDOSA) is FDA-approved as a biosimilar to STELARA for chronic inflammatory conditions, showing similar Three Stelara® (ustekinumab) biosimilars launched in the U. The FDA has approved the Stelara biosimilar Yesintek for indications matching the reference product, with a commercial launch date expected Ustekinumab-stba (Steqeyma; Celltrion), a biosimilar to ustekinumab (Stelara; Janssen Pharmaceuticals), has been launched in the US and is In August, the company also signed another Stelara biosimilar settlement deal with Formycon and Fresenius’ FYB202, setting its US launch date to Teva Pharmaceuticals and Alvotech got the FDA’s greenlight for their biosimilar to Johnson & Johnson’s blockbuster Stelara, which will launch in the U. Like its branded reference Starjemza gains FDA approval as the eighth ustekinumab biosimilar, enhancing treatment options for rheumatic and gastrointestinal conditions. in the past week, Alvotech / Teva’s Selarsdi™ (ustekinumab-aekn) on February 21, 2025, and Sandoz / Samsung Bioepis’s Sandoz and Biocon Biologics have each launched their biosimilar versions of Johnson & Johnson’s Stelara (ustekinumab). Three ustekinumab biosimilars enter the US market, expanding access to more affordable options referencing Stelara (ustekinumab), one of the most profitable Teva Pharmaceuticals and Alvotech got the FDA’s greenlight for their biosimilar to Johnson & Johnson’s blockbuster Stelara, which will launch in the U. 1 billion for the 12 months ending December 2024, per IQVIA.