AEON Biopharma presents ABP-450 development strategy as Botox biosimilar
AEON•AEON•AEON•AEON•AEON Biopharma is advancing ABP-450 through the FDA’s biosimilar pathway, targeting all 12 BOTOX therapeutic indications in a $3.5 billion U.S. market. The company plans to submit an investigational new drug application for a pharmacodynamic study in Q4 2026 and expects to start the study in Q1 2027.
AEON Biopharma is developing ABP-450 through the FDA’s biosimilar pathway, with the goal of targeting all 12 BOTOX therapeutic indications. The company plans to submit an investigational new drug application for a CMAP pharmacodynamic study in Q4 2026 and expects the study to begin in Q1 2027.
The company said FDA feedback opened the possibility of including prior ABP-450 versus BOTOX studies in the biosimilar evidence package, subject to appropriate scientific bridging. ABP-450 is expected to be priced below BOTOX.
