On November 17, 2025 Formycon AG (“Formycon”) announced development of a dupilumab biosimilar, FYB208, referencing Regeneron and Sanofi’s DUPIXENT. Dupilumab is a monoclonal antibody therapy designed to treat immunological disease by blocking interleukin 4 and interleukin 13 receptor signaling-induced type 2 inflammation. DUPIXENT is approved for the treatment of asthma, atopic dermatitis (eczema), chronic obstructive pulmonary disease (COPD), and several other inflammatory diseases.
Formycon announced the successful conclusion of a Technical Proof of Similarity comparison between FYB208 and DUPIXENT, “show[ing] high analytical comparability to the reference drug.” Based on the Technical Proof of Similarity, Formycon expects to “meet all requirements for approval of FYB208 without a comparative efficacy study (Phase III study).” Formycon has begun GMP manufacturing development and is currently planning a clinical pharmacokinetic study consistent with recent biosimilar guidance from the European Medicines Agency and the U.S. Food and Drug Administration.
Stay tuned to Big Molecule Watch for more news on biosimilar development.