AEON Biopharma announced positive biosimilarity results for ABP-450, demonstrating identical amino acid sequence and highly similar functional characteristics to BOTOX. The findings, submitted to the FDA ahead of a scheduled November 19, 2025 meeting, represent a significant milestone in the company's pursuit of the first full-label therapeutic BOTOX biosimilar in the United States.
Comprehensive Analytical Validation
The analytical package revealed 100% amino acid sequence identity between ABP-450 and BOTOX, based on sequence coverage of 93-99% for the five proteins comprising the 900kD botulinum toxin type A complex. The analysis examined more than 3,400 peptides across three lots of ABP-450 and two lots of BOTOX without detecting a single amino acid difference.
High analytical sensitivity was achieved through liquid chromatography/mass spectrometry (LC/MS), with no minor sequence deviations observed. According to the company, primary structural identity serves as a prerequisite for demonstrating biosimilar functional comparability.
Functional Similarity Demonstrated
Initial functional assays performed by Daewoong Pharmaceutical demonstrated similarity across multiple parameters. ABP-450 showed highly similar potency to BOTOX across two distinct assays: LD50 (in vivo biological activity) and CBPA (cell-based potency assay), supporting clinical dose predictability.
ELISA testing confirmed comparable vial-to-vial active ingredient content between ABP-450 and BOTOX, further supporting dose similarity and reliability. The biosimilar candidate also demonstrated functional cleavage of SNAP-25, consistent with the expected mechanism of action, though observed variability remains within the expected analytical range.
Established Global Foundation
ABP-450 represents an established asset with significant global validation. The product is the same botulinum toxin complex marketed by Evolus in the U.S. as Jeuveau for aesthetic indications and is approved in 69 countries worldwide. Manufacturing occurs at Daewoong Pharmaceutical's commercial-scale, cGMP facility, which has been inspected and approved by the FDA, EMA, and Health Canada.
"The confirmation of identical amino acid sequencing, together with strong similarity in potency and composition, provides compelling early evidence of biosimilarity to BOTOX," said Rob Bancroft, AEON's President and Chief Executive Officer. "These data build upon the extensive global body of evidence for ABP-450, which is already approved in 69 countries and manufactured at commercial scale by our partner Daewoong Pharmaceutical in FDA- and EMA-inspected facilities."
Regulatory Pathway and Market Opportunity
The FDA regulates biosimilars under the Public Health Service Act's 351(k) pathway, requiring developers to demonstrate that a proposed product is highly similar to an approved reference biologic with no clinically meaningful differences in safety, purity, or potency. Analytical similarity represents the most critical and data-intensive phase of this development process.
The analytical findings position ABP-450 as a potential first full-label therapeutic biosimilar to BOTOX in the U.S., targeting a therapeutic neurotoxin market that exceeds $3 billion annually. AEON holds exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories.
The company's upcoming FDA Type 2a meeting will focus on reviewing the analytical package and aligning on next steps in biosimilar development, with the goal of confirming whether any residual uncertainty requires limited clinical evaluation.
