The FDA approved Imuldosa (ustekinumab-srlf), a biosimilar to Stelara (ustekinumab), for the treatment of chronic inflammatory conditions, including psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The approval covers all indications for which Stelara is approved, with launch anticipated in the first half of 2025.

Stelara recorded $10.86 billion in worldwide sales in 2023. The approval is Accord BioPharma's second biosimilar, following the recent approval of Hercessi (trastuzumab-strf), a biosimilar to Herceptin.

The FDA's approval was based on a clinical development program demonstrating that Imuldosa is similar to Stelara in terms of pharmacokinetics, safety, tolerability, and efficacy. 

Imuldosa is intended to provide an affordable treatment option for chronic inflammatory conditions, according to the manufacturer. "For the millions of Americans living with chronic inflammatory conditions, which can be painful, and also can have a significant impact on quality of life, emotional well-being, and self-image, Imuldosa has the potential to be an affordable treatment option that provides similar benefits to the current standard of care."

Imuldosa is indicated for adult patients with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, and ulcerative colitis, as well as for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis or active psoriatic arthritis.

Safety considerations for Imuldosa include risk of serious infections, reactivation of latent infections, and increased malignancy risk. Patients should be evaluated for tuberculosis prior to initiating therapy, and live vaccines should be avoided during treatment. Common adverse reactions include nasopharyngitis, headache, and fatigue.