Aeon Biopharma Receives Constructive FDA Feedback on ABP-450 Biosimilar Program

AEON Biopharma has received constructive feedback from the FDA on its analytical similarity strategy for ABP-450, a biosimilar to BOTOX. The company plans to request a BPD Type 2b meeting in 2026 to discuss next steps in the development of ABP-450. The FDA has acknowledged the scientific challenges associated with characterizing botulinum neurotoxin complex and provided feedback on AEON's proposed development approach and analytical assessment plan.