FDA provided constructive feedback on Company's analytical similarity strategy under the 351(k) biosimilar pathway 

Company continues to execute its analytical program and plans to request a BPD Type 2b meeting with the FDA in 2026 to discuss next steps in the development of ABP-450 as a biosimilar to BOTOX® 
 

IRVINE, Calif., March 25, 2026 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. ("AEON" or the "Company") (NYSE:AEON), a biopharmaceutical company advancing ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX® (onabotulinumtoxinA) to achieve full-label U.S. market entry, today announced feedback from the U.S. Food and Drug Administration ("FDA" or the "Agency") following a successful Biosimilar Biological Product Development (BPD) Type 2a meeting.

During the meeting, held in January 2026, 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.