Sun Pharma’s sBLA for ILUMYA Accepted by US FDA
Filing Summary
Sun Pharmaceutical Industries Ltd announced the US FDA’s acceptance of its supplemental Biologics License Application (sBLA) for ILUMYA, targeting adults with active psoriatic arthritis. The FDA’s decision is anticipated by October 29, 2026. ILUMYA, previously approved for moderate-to-severe plaque psoriasis, is under review based on Phase 3 clinical studies, INSPIRE-1 and INSPIRE-2. These studies evaluated the drug’s efficacy and safety. Sun Pharma emphasizes its commitment to addressing psoriatic disease. ILUMYA has been approved in over 55 countries, including the US, India, and the EU.
Sun Pharmaceutical Industries Ltd has announced that the US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for ILUMYA (tildrakizumab-asmn). This application pertains to the treatment of adults with active psoriatic arthritis. The FDA’s regulatory action date for this sBLA is expected by October 29, 2026. This development follows ILUMYA’s previous approval in 2018 for treating moderate-to-severe plaque psoriasis in adults.
The sBLA submission is based on results from the INSPIRE-1 and INSPIRE-2 Phase 3 clinical studies. These studies assessed the efficacy and safety of ILUMYA in adult patients with active psoriatic arthritis. The top-line findings from these studies were reported in July 2025. The studies are global, multicenter, randomized, double-blind, and placebo-controlled, focusing on the administration of tildrakizumab 100 mg.
ILUMYA has been approved by over 55 health authorities worldwide, including in India, Japan, the European Union, China, Australia, and Canada. It is marketed under the brand name ILUMETRI in Europe by Almirall. Since its initial approval, ILUMYA has been used by nearly 140,000 patients globally, demonstrating durable skin clearance and a well-characterized safety profile over five years of clinical follow-up.
Sun Pharma has highlighted that approximately one in three psoriasis patients develop psoriatic arthritis. The company remains committed to serving patients with psoriatic disease. ILUMYA is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23), inhibiting its interaction with the IL-23 receptor. This action inhibits the release of pro-inflammatory cytokines and chemokines.
ILUMYA’s most common side effects include upper respiratory infections, injection-site reactions, and diarrhea. It is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or any of its excipients. The drug may increase the risk of infections, and treatment should not be initiated in patients with clinically important active infections until resolved or adequately treated.
Sun Pharmaceutical Industries Ltd is the world’s leading specialty generics company with a presence in innovative medicines, generics, and consumer healthcare products. It is the largest pharmaceutical company in India and a leading generic company in the U.S. and global Emerging Markets. Sun Pharma’s high-growth global Innovative Medicines portfolio spans dermatology, ophthalmology, and onco-dermatology, accounting for about 20% of company sales.