In a significant development in the biosimilar segment, the Subject Expert Committee (SEC) on Dermatology & Allergy has recommended granting permission to M/s Kemwell Biopharma Private Limited to conduct a comparative pharmacokinetic clinical study for its proposed Dupilumab biosimilar, ASP100.
The recommendation was made during the 6th SEC (Dermatology & Allergy) meeting of 2026, held on June 11, 2026, at the CDSCO Headquarters in New Delhi.
Kemwell Biopharma presented its proposal titled, “A randomized, double-blind, single-dose, parallel-group, three-arm comparative study assessing pharmacokinetics, safety, tolerability, and immunogenicity of ASP100 injection versus US-licensed Dupixent and EU-approved Dupixent in healthy adult human participants.” The study will be conducted according to Protocol No. CRD-070 Version 1.0 dated August 22, 2025.
After detailed scientific deliberations, the committee recommended approval for conducting the comparative pharmacokinetic study of ASP100 (Dupilumab) Injection 300 mg/2 mL, developed by Kemwell Biopharma, against both the US-licensed and European Union-approved versions of Dupixent.
The proposed clinical trial will evaluate key parameters including pharmacokinetics, safety, tolerability, and immunogenicity following a single dose administration in healthy adult volunteers. Such studies are critical for establishing biosimilarity by demonstrating that the proposed biosimilar performs comparably to the reference products.
Dupilumab is a monoclonal antibody widely used in the treatment of several inflammatory diseases, including moderate-to-severe atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis. The reference product, marketed as Dupixent, has emerged as one of the world's leading biologic therapies in dermatology and allergy-related conditions.
The SEC's recommendation marks an important step in the clinical development pathway for ASP100. Upon obtaining final regulatory approval from CDSCO, the study will generate evidence required to support the biosimilar development program and may contribute to expanding access to Dupilumab-based therapies in India in the future.
