GS101 Granted FDA Positive Feedback: Single-Dose PK Study Supports 351(k) Filing

In March 2026, following a Biosimilar Biological Product Development (BPD) Type 2b meeting with the FDA, Jiangsu GenScend Biopharma Co., Ltd. received clear feedback that its proposed CMC and clinical development plan for GS101 (dupilumab biosimilar) is reasonable. The FDA indicated that a Phase 3 comparative efficacy study may be waived, provided that robust analytical similarity is demonstrated. A single‑dose pharmacokinetic (PK) similarity study in healthy Chinese subjects, together with immunogenicity assessment, is considered sufficient to support a future 351(k) Biologics License Application (BLA). The Company is advancing the regulatory submission of GS101 accordingly.

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