On 17 November 2025, Formycon revealed that it is developing FYB208, a biosimilar candidate to Sanofi/Regeneron’s Dupixent® (dupilumab). According to Formycon, preclinical development is completed and it is working on the study design for the planned clinical pharmacokinetic (PK) study in close alignment with the European Medicines Agency (EMA) and the US FDA.
According to Dr. Andreas Seidl, Formycon’s CSO, Formycon believes it will “be able to meet all requirements for approval of FYB208 without a comparative efficacy study (Phase III study).”
There are a number of other dupilumab biosimilars under development. In August 2025, CSPC Pharmaceutical announced that it received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection. 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 2023, May 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.