Goodwin
Accord BioPharma Inc. announced on October 14, 2024 that the FDA had approved IMULDOSA, a biosimilar product to Johnson & Johnson’s STELARA (ustekinumab). IMULDOSA is indicated for the treatment chronic inflammatory conditions such as psoriasis and psoriatic joint disease, Crohn’s disease, ulcerative colitis, etc. IMULDOSA, the fifth ustekinumab biosimilar approved by the FDA, is Accord BioPharma’s second FDA-approved product in the United States. IMULDOSA, the fifth ustekinumab-biosimilar approved by FDA, was received just days later on October 17, 2024. The Committee for Medicinal Products for Human Use recommended that the European Commission grant a marketing authorization for adults and children with psoriasis, psoriatic arthritis, or Crohn’s. This opinion brings IMULDOSA one step closer to receiving a decision from the European Commission.
