FDA Approves Fifth Ustekinumab Biosimilar

The US Food and Drug Administration (FDA) has approved ustekinumab-srlf (Imuldosa) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions.

This is the fifth ustekinumab biosimilar approved by the FDA, and it is expected to become available in the first half of 2025. 

Stelara, manufactured by Johnson & Johnson, has a list price of $25,497.12 per 90-mg dose, according to the drug website, and its worldwide sales in 2023 totaled $10.86 billion. 

Ustekinumab-srlf, a human interleukin (IL)–12 and IL-23 antagonist, is indicated for the treatment of:

• Patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; 
• Patients 6 years or older with active psoriatic arthritis; 
• Adult patients with moderately to severely active Crohn’s disease; and 
• Adult patients with moderately to severely active ulcerative colitis. 

It is administered via subcutaneous injection in 45 mg/0.5 mL and 90 mg/mL prefilled syringes or via intravenous infusion in a 130 mg/26 mL (5 mg/mL) single-dose vial. 

Ustekinumab-srlf was jointly developed by Dong-A Socio Holdings, based in South Korea, and Meiji Seika Pharma, a Japanese pharmaceutical company. In 2021, Intas Pharmaceuticals acquired commercialization rights to the drug; Accord BioPharma, the US specialty division of Intas Pharmaceuticals, will handle commercialization in the United States. 

This is the second FDA-approved biosimilar from Accord BioPharma. The agency approved trastuzumab-strf (Hercessi), a biosimilar for Herceptin, in April 2024 for the treatment of HER2-overexpressing breast and gastric cancers.