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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Organon has swelled its immunology biosimilar portfolio after acquiring the US commercial rights to Bio-Thera’s tocilizumab biosimilar from Biogen, which last year decided to retain its interests in biosimilars following a lengthy strategic review.
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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.
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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.
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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.
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Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.
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Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA’s CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin.
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With Celltrion having just received approval for its US Actemra (tocilizumab) biosimilar and having just launched its ustekinumab rival to Stelara – and with the introduction of the Korean developer’s denosumab rivals to Prolia and Xgeva just around the corner – 2025 is set to be a busy year, Celltrion USA chief commercial officer Thomas Nusbickel tells Generics Bulletin.