FDA Approves Imuldosa, the Fifth Stelara Biosimilar

The FDA has approved Imuldosa (ustekinumab-srlf), a biosimilar referencing Stelara, to treat patients with autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

The FDA approval of Imuldose was granted based on a comprehensive clinical development program, which showed it is similar to Stelara in terms of pharmacokinetic characteristics, safety, tolerability, and efficacy.

Imuldosa was developed jointly by Dong-A ST, a Seoul, Republic of Korea-based company, and Meiji Seika Pharma. It will be marketed in the United States by Accord BioPharma, a subsidiary of Intas Pharmaceuticals.

Accord anticipates a commercial launch in the first half of 2025. Due to patent litigation settlements, companies are not allowed to launch their ustekinumab biosimilars until early 2025.

Stelara, developed by Janssen, a Johnson & Johnson company, is a high-cost drug with a list price of $13,836 for one month’s supply. It generated $10.86 billion in revenue globally in 2023 compared with $6.4 billion the previous year. In the first half of this year, Stelara generated worldwide sales of $5.3 billion, up 1.8% from the first half of 2023, according to Johnson and Johnson’s second quarter earnings.

Stelara is also one of the first 10 medications selected by CMS for drug price negotiation, which will go into effect at the start of 2026.

Imuldosa is the fifth Stelar biosimilar to be approved for the U.S. market and comes shortly after the FDA approved Otulfi (ustekinumab-aauz) in September 2024. Pyzchiva (ustekinumab-ttwe) was approved in July 2024, Wezlana (ustekinumab-auub) in November 2023, and Selarsdi (ustekinumab-aekn) in April 2024.

Related: Evernorth Will Offer a Private-Label Stelara Biosimilar in 2025

Last month, Evernorth Health Services announced that in 2025, itwill offer clients and their members a private-label biosimilar of Stelara. The interchangeable biosimilar will be produced for Evernorth’s affiliate private-label distributor, Quallent Pharmaceuticals, and will have a price that is more than 80% lower than the list price of Stelara. In a press release, Evernorth indicated that this represents an opportunity for significant savings.