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Formycon Announces New Dupilumab Biosimilar Candidate
Formycon Announces New Dupilumab Biosimilar
About this update from Formycon Ag
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 . The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. Mr R. Samuel Herron Goodwin Procter LLP The New York Times Building 620 Eighth Avenue New York NY 10018 UNITED STATES Tel: 212813 8800 E-mail: [email protected] URL: www.goodwinlaw.com © Mondaq Ltd, 2025 - Tel. +44 (0)20 8544 8300 - http://www.mondaq.com, source Business Briefing