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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.
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