FDA Approves Imuldosa, a Biosimilar to Stelara
Accord BioPharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has 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 FDA approved Imuldosa for all indications of its reference medicine, Stelara.
- FDA approval of Imuldosa was granted based on a comprehensive clinical development program. The data showed that Imuldosa is similar to its reference product Stelara in terms of pharmacokinetic characteristics, safety, tolerability, efficacy and that Imuldosa adheres to current biosimilar guidance from the FDA.
- Imuldosa has the potential to be an affordable treatment option that provides similar benefits to the current standard of care.
Source: Accord BioPharma
