Aeon Biopharma announces outcome from FDA biosimilar advisory meeting

AEON Biopharma announced receipt of the formal minutes from a recent Biosimilar Initial Advisory Meeting with the U.S. Food and Drug Administration for ABP-450 injection as a biosimilar utilizing BOTOX as the reference product. The purpose of the meeting was to seek alignment with the FDA on proposed 351(k) regulatory pathway and determine the next steps in the development pathway. The Company believes it is aligned with the FDA on key requirements, including additional analytical studies to be completed to fulfill the standard regulatory requirements for a comparative analytical assessment. The Company is actively planning comparative analytical studies, which are expected to commence in Q4 2024. A Biosimilar Biological Product Development Type 2 meeting with FDA is planned for 2025 to discuss the outcome from these studies and determine the next steps in development, including a potential comparative clinical program. As previously announced, the Company expects it will need to conduct, subject to securing funding, a Phase 3 program to compare ABP-450 with BOTOX as the reference product. Under the 351(k) regulatory framework, comparative clinical studies are only required when it is necessary to address any residual uncertainty regarding biosimilarity following a comparative analytical assessment. The necessity of any specific comparative clinical studies will be determined after the FDA has reviewed the results from the CAA, which AEON currently anticipates in 2025.