With news of a third settlement over a proposed Stelara (ustekinumab) biosimilar in the US, a pattern seems to be emerging: the earlier you settle with Johnson & Johnson, the earlier your rival to Stelara can hit the market.
Another US Stelara Settlement Arrives, This Time For Fresenius And Formycon
Deal With Johnson & Johnson Allows US Biosimilar Ustekinumab Entry In 2025
A third settlement has been struck allowing a Stelara biosimilar to hit the US market in 2025, with partners Fresenius and Formycon agreeing terms with Johnson & Johnson that offer a launch date slightly later than previous settlers.

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India’s Dr Reddy’s and China’s Bio-Thera have struck a deal covering ustekinumab and golimumab biosimilars in multiple markets in south-east Asia.
Cipla has bolstered its ophthalmology portfolio and increased its global offering after chalking up an agreement to add Formosa Pharmaceuticals’ USFDA-approved clobetasol propionate 0.05% ophthalmic suspension.
Along with financial backing from the Canadian government, a fresh, decade-long partnership with Sandoz Canada will allow Delpharm to carry out modernization plans for its manufacturing facility in Boucherville, securing the local supply chain for sterile injectable medicines.
Sweden’s Xbrane has struck a deal to transfer its R&D operations in Sweden and its Cimzia (certolizumab pegol) biosimilar candidate to Alvotech, in a transaction worth around $27m. However, Xbrane told Generics Bulletin that it was not getting out of biosimilar development altogether.
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With sales and profits shooting up in 2024, Alvotech has revealed plans to rapidly accelerate development to add between four and six programs to its pipeline of biosimilars every year, while at the same time unveiling details of several new brands that it will be seeking to challenge. The firm has also set out longer-term financial targets that anticipate more than trebling its revenues in the next three years.
The Chinese player reported its second profitable year in a row, with growth in sales reported across its marketed portfolio and further milestones in the near future.
India’s Dr Reddy’s and China’s Bio-Thera have struck a deal covering ustekinumab and golimumab biosimilars in multiple markets in south-east Asia.