Formycon Reaches Milestone with FYB208 for Dupixent®

Formycon AG has achieved a significant development milestone with its biosimilar candidate FYB208 for Dupixent® (dupilumab). The company has successfully demonstrated the Technical Proof of Similarity (TPoS), showing high analytical comparability to the reference drug. This biosimilar aims to expand access to therapy for patients suffering from chronic inflammatory diseases like COPD, asthma, and atopic dermatitis.

The biosimilar candidate is anticipated to enter the rapidly growing market, where Dupixent® has seen significant growth, with revenues reaching about US$8 billion in the first half of 2025. Formycon holds full project and commercialization rights and is working closely with the EMA and FDA to advance FYB208 through the necessary regulatory processes.

Dr. Andreas Seidl, Formycon's CSO, highlighted their confidence in proceeding without a comparative efficacy study, allowing for a streamlined development timeline. This development exemplifies Formycon's expertise in biosimilars and aligns with its strategy to provide affordable treatments.