Sun Pharmaceutical secures USFDA’s nod for review of ILUMYA

17 Mar 2026 Evaluate

Sun Pharmaceutical Industries has secured United States Food and Drug Administration’s (USFDA) acceptance for review of the supplemental Biologics License Application (sBLA) for ILUMYA for the treatment of adults with active psoriatic arthritis. The FDA regulatory action date for this sBLA is expected by October 29, 2026. 

If approved, this would mark a new indication for ILUMYA following its USFDA approval in 2018 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Scalp and nail plaque psoriasis sBLAs were approved in April 2024, and December 2025, respectively. ILUMYA has also received marketing authorization from over 55 worldwide health authorities since its original approval, including in India, Japan, the European Union, China, Australia and Canada.

The sBLA is based on the results from the INSPIRE-1 and INSPIRE-2 Phase 3 clinical studies evaluating the efficacy and safety of ILUMYA in adult patients with active psoriatic arthritis. Top-line findings from these studies were reported in July 2025. 

Sun Pharmaceutical Industries is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.

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