AEON Biopharma Reports Positive FDA Biosimilar Meeting

AEON Biopharma Advances ABP-450 Development with FDA Alignment

IRVINE, Calif., Sept. 30, 2024 — AEON Biopharma, Inc. (NYSE: AEON), a clinical-stage biopharmaceutical company, announced that it has received formal minutes from a recent Biosimilar Initial Advisory (BIA) Meeting with the U.S. Food and Drug Administration (FDA) regarding the development of ABP-450 (prabotulinumtoxinA) as a biosimilar, using BOTOX® (onabotulinumtoxinA) as the reference product. The meeting focused on aligning with the FDA on the proposed 351(k) regulatory pathway and determining the subsequent steps for development.

AEON is confident it has reached a consensus with the FDA on key regulatory requirements, including the need for additional analytical studies to meet the comparative analytical assessment (CAA) standards. The company plans to begin these comparative analytical studies in the fourth quarter of 2024. In 2025, AEON intends to hold a Biosimilar Biological Product Development (BPD) Type 2 meeting with the FDA to review the results from these studies and confirm the remaining proposed study package.

Commenting on the progress, Marc Forth, AEON’s President and Chief Executive Officer, expressed optimism: "We are encouraged by the outcome of our recent FDA meeting and the opportunity to advance the development of prabotulinumtoxinA using the 351(k) biosimilar regulatory pathway. We now have a clear path forward and plan to initiate analytical studies in Q4 2024. This biosimilar approach could potentially allow us to bring prabotulinumtoxinA to the U.S. market for all BOTOX’s currently approved and future therapeutic indications under a single approval."

AEON anticipates that, subject to securing funding, a Phase 3 program will be necessary to compare ABP-450 (prabotulinumtoxinA) with BOTOX® (onabotulinumtoxinA). Under the 351(k) regulatory framework, comparative clinical studies are required only to address any residual uncertainty regarding biosimilarity after completing the CAA. The need for specific comparative clinical studies will be determined following FDA's review of the CAA results, which AEON expects in 2025.

About AEON Biopharma

AEON Biopharma is a clinical-stage biopharmaceutical company dedicated to developing its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA), for serious medical conditions, with a primary focus on the neurosciences market. ABP-450 is the same botulinum toxin complex approved and marketed for cosmetic uses by Evolus under the name Jeuveau. Manufactured by Daewoong in a facility compliant with current Good Manufacturing Practice (cGMP) and approved by the U.S. FDA, Health Canada, and the European Medicines Agency, AEON’s ABP-450 is already approved as a biosimilar in Mexico and India.

The company holds exclusive development and distribution rights for therapeutic applications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and selected international territories. AEON has assembled an experienced management team specializing in biopharmaceutical and botulinum toxin development and commercialization.

By advancing the development of ABP-450, AEON aims to expand its presence in the competitive biopharmaceutical market, leveraging its proprietary formulations to address medical needs in the neurosciences sector.