FDA Greenlights IMULDOSA: A Game-Changer in Biosimilar Treatments

Accord BioPharma has received FDA approval for IMULDOSA, a biosimilar to STELARA, for treating chronic inflammatory conditions like psoriasis and Crohn's disease. Scheduled for a 2025 launch, it aims to offer an affordable treatment alternative, marking Accord's second FDA-approved biosimilar, after HERCESSI.

Accord BioPharma, Inc., a division of Intas Pharmaceuticals, has announced FDA approval for IMULDOSA (ustekinumab-srlf), a biosimilar equivalent to STELARA. This approval marks a significant step toward providing affordable treatment options for chronic inflammatory conditions, which affect millions in the U.S.

IMULDOSA has been approved for the same indications as its reference medicine, including psoriasis and Crohn's disease. Accord BioPharma plans a commercial launch in early 2025, aiming to deliver lower-cost alternatives to existing treatments.

This notable FDA approval underscores Accord BioPharma's growing presence in the biosimilar market, following the earlier approval of HERCESSI, and bolsters their commitment to accessible healthcare solutions, as stated by U.S. president Chrys Kokino.

(With inputs from agencies.)