AEON Biopharma, Inc. has announced promising biosimilarity results for its product ABP-450, which aims to establish itself as a biosimilar to BOTOX (onabotulinumtoxinA). The company confirmed an identical amino acid sequence and highly similar functional analysis data, findings that were submitted to the US FDA ahead of a key meeting scheduled for November 19, 2025. This analytical package is critical as it lays the groundwork for AEON’s 351(k) biosimilar pathway, essential for gaining market entry in the competitive therapeutic neurotoxin sector.
The results indicate a 100% amino acid sequence identity between ABP-450 and BOTOX, with extensive analysis showing no deviations across multiple lots. Functional assays further demonstrated comparable potency and enzymatic activity, reinforcing the product’s potential. These findings not only bolster AEON’s confidence but also align with the stringent requirements set forth by the FDA for biosimilar approval, which mandate no clinically meaningful differences in safety, purity, or potency.
As ABP-450 is already approved in 69 countries and manufactured under rigorous standards, these results position AEON favorably in the U.S. market, which is valued at over $3 billion annually. The upcoming FDA meeting will be pivotal in determining the next steps for AEON’s biosimilar development, potentially setting a precedent for the first full-label therapeutic biosimilar to BOTOX in the U.S. market.
Use the database as your supply chain compass →
