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27 August 2025

Accord BioPharma Announces Commercial Launch Of IMULDOSA® (ustekinumab-srlf) Prefilled Syringes In The United States

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Goodwin Procter LLP

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On August 18, 2025, Accord BioPharma, Inc. ("Accord BioPharma") announced the commercial launch of IMULDOSA® (ustekinumab-srlf), a biosimilar to STELARA® (ustekinumab)...
United States Food, Drugs, Healthcare, Life Sciences

On August 18, 2025, Accord BioPharma, Inc. ("Accord BioPharma") announced the commercial launch of IMULDOSA® (ustekinumab-srlf), a biosimilar to STELARA® (ustekinumab) in the United States. IMULDOSA® is supplied as single-dose prefilled syringes for subcutaneous use in 45 mg/0.5 mL and 90 mg/mL strengths or as a single-dose vial for intravenous infusion in 130 mg/26 mL (5 mg/mL) strength. It is approved for the same indications as the reference product, including the treatment of adults with plaque psoriasis, psoriatic arthritis, or Crohn's disease and the treatment of pediatric plaque psoriasis or psoriatic arthritis for patients six years and older.

According to Accord BioPharma, "IMULDOSA prefilled syringes, which would represent the majority of the presentations in the ustekinumab market, are priced at the lowest wholesaler acquisition cost (WAC) among all branded ustekinumab biosimilars at a 92% discount from STELARA."

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