CHMP Clears Path for GS101: Single‑Dose PK Study and Immunogenicity Assessment Sufficient for MAA

In February 2026, the EMA CHMP adopted positive scientific advice confirming that a tailored clinical development program without a dedicated comparative efficacy study may be acceptable for GS101. The CHMP agreed that robust analytical similarity data, together with a single-dose pharmacokinetic similarity study in healthy subjects and immunogenicity assessment, would be sufficient to support a marketing authorization application (MAA) for GS101 as a biosimilar to Dupixent®. The Company will integrate the CHMP’s recommendations to advance the global registration of GS101 injection.

The release as fetched from its publisher. genscend.com ↗