AEON Biopharma Receives FDA Support for ABP-450 Analytical Strategy, Targets 2026 Milestone
FDA provided constructive feedback on AEON Biopharma’s analytical similarity strategy for its ABP-450 biosimilar under the 351(k) pathway, endorsing its methodologies to characterize the 900 kDa botulinum neurotoxin complex. AEON plans to complete the bulk of its analytical comparability program in 2026 and request a BPD Type 2b meeting.
1. FDA Feedback on Analytical Similarity
The FDA provided constructive guidance on AEON’s analytical similarity strategy for ABP-450 under the 351(k) biosimilar pathway, acknowledging the scientific approach and data supporting characterization of the 900 kDa botulinum neurotoxin complex.
2. 2026 Analytical Milestones
AEON plans to complete the majority of its analytical comparability program throughout 2026, leveraging validated methodologies to build a comprehensive similarity package for full-label approval.
3. Upcoming BPD Type 2b Meeting
Following the Type 2a meeting feedback, AEON intends to request a BPD Type 2b meeting later in 2026 to outline clinical study requirements and advance ABP-450 toward therapeutic indication approvals.