The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided positive scientific advice for the development plan of the dupilumab biosimilar GS101 injection. The CHMP endorsed the proposed quality and clinical development strategy and agreed that, based on solid evidence for similarity, such a tailored clinical approach may be acceptable without a comparative efficacy study (CES).
The Company will fully consider the scientific advice from the EMA CHMP in GS101’s subsequent development, optimizing and improving the similarity assessment plan and comparative PK study design. The Company will maintain proactive communication with the EMA to advance the global registration and marketing process of GS101 injection.