In a significant development for India’s biosimilar industry, the Subject Expert Committee (SEC) on Dermatology & Allergy has recommended granting permission to 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 meeting of 2026 held on June 11 at the CDSCO headquarters in New Delhi.
The approval recommendation marks an important milestone in the development of a biosimilar version of Dupilumab, a globally recognized biologic therapy used to treat several inflammatory and allergic disorders. The move also highlights India’s growing capabilities in developing complex biologics and biosimilars for domestic and international markets.
Kemwell Biopharma presented a proposal for a randomized, double-blind, single-dose, parallel-group, three-arm comparative study designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of ASP100. The study will compare the proposed biosimilar with both the US-licensed and European Union-approved versions of Dupixent, the reference product containing Dupilumab.
Following detailed scientific discussions, the committee recommended approval for conducting the comparative pharmacokinetic study of ASP100 (Dupilumab) Injection 300 mg/2 mL. The study will be carried out in healthy adult volunteers and is intended to generate critical clinical evidence supporting the biosimilar development program.
Comparative pharmacokinetic studies are an essential component of biosimilar development. Unlike conventional generic medicines, biosimilars are complex biological products that require extensive analytical and clinical evaluation to demonstrate similarity with the reference product. These studies help establish that the biosimilar behaves in the body in a manner comparable to the original biologic while maintaining similar safety and efficacy profiles.
The proposed trial will focus on four key parameters: pharmacokinetics, safety, tolerability, and immunogenicity. Demonstrating similarity in these areas is crucial for obtaining regulatory approval and advancing the product toward commercialization.
Dupilumab is a monoclonal antibody that has transformed the treatment of several chronic inflammatory diseases. It works by targeting specific immune pathways associated with type-2 inflammation, helping control symptoms and disease progression. The drug is widely prescribed for conditions such as moderate-to-severe atopic dermatitis, severe asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis.
Marketed globally as Dupixent, the biologic has become one of the most successful therapies in dermatology and allergy treatment. However, the high cost of biologic therapies often limits patient access, particularly in developing countries. The development of biosimilars such as ASP100 has the potential to improve affordability and expand access to advanced treatment options.
India has emerged as a major player in the global biosimilars market, supported by strong manufacturing capabilities, scientific expertise, and a growing focus on biotechnology innovation. Several Indian pharmaceutical companies are actively developing biosimilars targeting blockbuster biologic drugs whose demand continues to rise worldwide.
The SEC’s recommendation represents an important step forward for Kemwell Biopharma’s biosimilar program. Once final regulatory approval is granted by CDSCO, the clinical study can proceed and generate the evidence required for future regulatory submissions.
If successfully developed and approved, ASP100 could provide a cost-effective alternative to Dupixent and contribute to broader patient access to Dupilumab-based therapies in India and other markets. The development also reinforces India’s position as a leading hub for biosimilar research, development, and manufacturing.
As demand for biologic medicines continues to grow globally, the advancement of ASP100 reflects the increasing role of Indian companies in delivering innovative and affordable healthcare solutions. The successful completion of the proposed study will be a key milestone in bringing another important biosimilar therapy closer to patients who need it.
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