Our approach
Built on a Well-Validated Toxin Complex
AEON’s development program is built around ABP-450 (prabotulinumtoxinA), the same 900 kDa botulinum toxin type A complex that is approved for aesthetic use in the United States, the European Union, and Canada, and approved across a total of 69 countries worldwide for aesthetic and therapeutic indications, including approvals as a biosimilar in multiple international markets. This global experience provides deep real-world insight into the molecule’s performance, consistency, and safety – an advantage we now bring into the therapeutic biosimilar space.
Biosimilarity as Our Design Principle
We are developing ABP-450 as a branded biosimilar to Botox®, guided by the FDA’s biosimilar framework. Our work centers on a comprehensive analytical program evaluating structural, functional, and biological similarity to the reference product. By focusing on high-quality analytical evidence and orthogonal assay systems, we aim to meet the scientific standards that support biosimilarity and indication extrapolation rather than pursuing traditional, indication-by-indication clinical development.
Therapeutic-Only Focus for Greater System Value
AEON is solely focused on therapeutic botulinum toxin indications and is not pursuing aesthetic use. This dedicated focus enables closer alignment with payers, providers, and health systems that seek to expand access to medically necessary treatments while managing cost. By concentrating exclusively on therapeutic care, we can design pricing and access strategies that reflect both clinical importance and broader healthcare system needs.
Disciplined, Stepwise Development with Regulators
Our development strategy follows a structured engagement with regulators consistent with how biosimilars are evaluated. We have generated a foundational body of analytical data – including primary structure, functional characterization, and comparative performance attributes – that informs our discussions and helps shape the scope of subsequent development needs. This work represents an important component of a disciplined, iterative process that enables the program to advance in a scientifically rigorous and efficient manner.
Full-Label Ambition, Evidence-Driven Execution
The therapeutic neurotoxin market is currently defined by a single reference product used across a broad set of indications. Our goal is to introduce a branded biosimilar that can ultimately serve that full therapeutic footprint, subject to FDA review. By building our program around rigorous analytical similarity, a well-characterized toxin complex, and an established manufacturing platform, we are designing ABP-450 to function as a high-quality, full-label therapeutic alternative that integrates seamlessly into existing clinical practice and payer frameworks.
To learn more about our indications in development, visit our pipeline page.
1. Lagueny A, Burbaud P. Mécanisme d’action, indication et résultats des traitements par la toxine botulinique. Mechanism of action, clinical indication and results of treatment of botulinum toxin. Neurophysiol Clin. 1996;26(4):216-226. doi:10.1016/s0987-7053(96)85003-9 2. ABP-450 is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus under the name Jeuveau (US) and Nuceiva (Ex-US). United States Securities and Exchange Commission. AEON Biopharma, Inc.: Form S-1/A [Amendment No. 2]. EDGAR Archives. Published 2021. Accessed May 5, 2023.