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Dong-A ST Reports the US FDA’s Approval of Imuldosa (Biosimilar, Stelara) 

Shots: 

  • Following the BLA submission by Accord BioPharma (Intas Pharmaceuticals’ subsidiary) in 2023, the US FDA has granted approval to Imuldosa, a biosimilar version of Stelara (ustekinumab). Its MAA has also been accepted by the EMA in 2023 
  • Intas Pharmaceuticals with its subsidiaries (Accord BioPharma & Accord Healthcare) will commercialize the biosimilar across the US, EU, UK & Canada while Meiji & Dong-A ST will provide Imuldosa for the same, as per an agreement b/w the companies signed in 2021 
  • Imuldosa (ustekinumab-srlf) is a recombinant mAb developed as an interchangeable for treating autoimmune and inflammatory diseases incl. plaque psoriasis, psoriatic arthritis, Crohn’s disease & ulcerative colitis 

Ref: Dong-A ST | Image: Dong-A ST| Press Release

Related News:- Dong-A ST Receives the CHMP’s Positive Opinion for Imuldosa (Biosimilar, Stelara) 

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