AEON Eyeing FDA Meeting On Botox Biosimilar By The End Of 2025

California-Based Firm Has Begun Primary Analytical Studies For ABP-450 Candidate

26 Mar 2025

With an ambitious goal to file a biosimilar to the world-renowned Botox brand via the US FDA’s 351(k) regulatory pathway, AEON Biopharma has revealed the latest steps in its plan.

Bottles of Botulinum Toxin or Botox were rowed in the Surgery clinic display for customer showing off. Bangkok, Thailand September 2, 2017 — • Source: Shutterstock

AEON Biopharma has kicked off the primary analytical studies that are required for its ABP-450 proposed biosimilar to Botox (onabotulinumtoxinA) to fulfill the standard regulatory requirements for a comparative analytical assessment, under plans to file eventually the biosimilar via the US Food and Drug Administration’s 351(k) regulatory pathway.

The development comes after AEON last year received the formal minutes from a biosimilar initial advisory...