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CSPC’s Biosimilar Dupilumab PRC Clinical Trials Approved

Aug 19, 2025

On 19 August 2025, CSPC Pharmaceutical announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection, biosimilar to Sanofi/Regeneron’s Dupixent®.  According to CSPC, the product, which is indicated for the treatment of moderate-to-severe atopic dermatitis in adults, has been demonstrated to be highly similar to Dupixent® in terms of quality, safety and efficacy in pharmaceutical and non-clinical studies.

There are a number of other dupilumab biosimilars under development.  In June 2025, Bio-Thera Solutions and Costa Rican-based SteinCares announced an agreement to commercialise biosimilar dupilumab across Latin America, with Bio-Thera responsible for product development and supply, and SteinCares responsible for commercialisation.

Alvotech and Advanz entered into partnership agreements in February 2023May 2023 and June 2024 for the commercialisation of various biosimilars, including dupilumab, in Europe and certain other countries, with Alvotech responsible for development, and Advanz responsible for commercialisation.