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.