Pharmaceutical company Accord BioPharma, Inc., the US division of Intas Pharmaceuticals, announced on Monday that it has received US FDA approval for IMULDOSA (ustekinumab-srlf), a biosimilar to STELARA.

IMULDOSA is approved to treat chronic inflammatory conditions such as psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. STELARA generated USD10.86bn in global sales in 2023, highlighting strong market potential for IMULDOSA, which is expected to launch commercially in the US in early 2025.

This is Accord BioPharma's second FDA-approved biosimilar, following HERCESSI (trastuzumab-strf) earlier this year. IMULDOSA's approval is based on clinical data demonstrating its similarity to STELARA in pharmacokinetics, safety and efficacy.

Initially developed by Dong-A Socio Holdings and Meiji Seika Pharma, IMULDOSA's US commercialization rights were acquired by Intas Pharmaceuticals in 2021. Accord BioPharma plans to introduce more biosimilars in the US over the next five years.