AEON Biopharma plans IND filing for CMAP trial of ABP-450 biosimilar in Q4 2026
AEON•AEON Biopharma plans to file an IND in Q4 2026 for a CMAP pharmacodynamic study of its ABP-450 biosimilar, with trial initiation targeted for Q1 2027. FDA meeting minutes support a potentially streamlined biosimilar path, pending whether integrated evidence resolves remaining questions.
1. Planned study
AEON Biopharma said it plans to submit an IND in Q4 2026 for a CMAP pharmacodynamic study of ABP-450, with trial initiation targeted for Q1 2027.
2. FDA feedback
The company received FDA Type 2b meeting minutes that support a potentially streamlined biosimilar path versus BOTOX. Previously completed head-to-head studies may support the filing if scientifically bridged. AEON aims to reduce or avoid a standalone comparative efficacy study, pending whether an integrated evidence package resolves remaining biosimilarity questions; it expects to return to the FDA in 2027 to support a potential 351(k) BLA submission.
