The FDA has approved ustekinumab-srlf (Imuldosa) as a biosimilar to Stelara for the treatment of multiple inflammatory conditions. This is the fifth ustekinumab biosimilar approved by the FDA and is expected to be available in the first half of 2025. The drug is indicated for patients with plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It is administered via subcutaneous injection or intravenous infusion. Ustekinumab-srlf was jointly developed by Dong-A Socio Holdings and Meiji Seika Pharma, with commercialization rights acquired by Intas Pharmaceuticals. This is the second FDA-approved biosimilar from Intas Pharmaceuticals, following trastuzumab-strf (Hercessi) for HER2-overexpressing breast and gastric cancers.
Source link
FDA Approves Fifth Ustekinumab Biosimilar
