On October 14, 2024, Accord BioPharma, Inc. announced that the FDA has approved IMULDOSA (ustekinumab-srlf), a biosimilar to Johnson & Johnson’s STELARA (ustekinumab), indicated for the treatment of chronic inflammatory conditions, including psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. IMULDOSA is Accord BioPharma’s second FDA-approved biosimilar product in the United States, after approval of HERCESSI (trastuzumab-strf) in April 2024. IMULDOSA is the fifth ustekinumab biosimilar approved by the FDA.
Just days later, on October 17, 2024, IMULDOSA received a positive opinion from the Committee for Medicinal Products for Human Use, recommending that the European Commission grant marketing authorization for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease. This opinion brings IMULDOSA closer to receiving a European Commission decision.
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