With a US filing for its Stelara (ustekinumab) biosimilar in hand, Biocon Biologics has now secured a February 2025 launch date for its proposed Bmab 1200 version, assuming US Food and Drug Administration approval.
Biocon Stelara Settlement Places Firm Among Earlier US Rivals
Indian Biosimilars Giant Secures Early 2025 Launch Date For Ustekinumab
Biocon Biologics has secured a launch date for its planned US biosimilar to Stelara that puts it ahead of some of the competition.
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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.