Aeon Biopharma Receives FDA Feedback to Advance ABP-450 Development
Aeon Biopharma announced feedback from the FDA following a biosimilar biological product development Type 2a meeting. During the meeting, held in January, the FDA reviewed the company's proposed analytical similarity strategy under the 351(k) biosimilar pathway and provided feedback supporting the company's planned analytical development approach. The agency acknowledged the scientific challenges associated with characterizing a 900 kDa botulinum neurotoxin complex, provided constructive feedback on the company's proposed development approach and analytical assessment plan, and noted that Aeon's analytical methodologies appeared reasonable to support advancement of the program toward a comprehensive analytical similarity package. The company believes this feedback provides a clear framework for the remaining analytical components of its biosimilar development program and plans to complete the majority of its analytical comparability program in 2026. Aeon is currently planning to request a BPD Type 2b meeting in 2026 to discuss the next phase of the development program to support approval of ABP-450 as a biosimilar to Botox across all approved therapeutic indications.
