AEON 'Aligned' With FDA for Botox Biosimilar

AEON Biopharma, Inc., a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex under a 351(k) biosimilar pathway, announced receipt of the formal minutes from a recent Biosimilar Initial Advisory (BIA) Meeting with the US Food and Drug Administration (FDA) for ABP-450 (prabotulinumtoxinA) injection as a biosimilar utilizing BOTOX® (onabotulinumtoxinA) as the reference product. The purpose of the meeting was to seek alignment with the FDA on proposed 351(k) regulatory pathway and determine the next steps in the development pathway.

The company said in a press release that it believes it is aligned with the FDA on key requirements, including additional analytical studies to be completed to fulfill the standard regulatory requirements for a comparative analytical assessment (CAA). The company is actively planning comparative analytical studies, which are expected to commence by the end of 2024. A Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA is planned for 2025 to discuss the outcome from these studies and determine the next steps in development, including a potential comparative clinical program.

“We are encouraged by the outcome from the recent FDA meeting and the opportunity to advance our development of prabotulinumtoxinA utilizing the 351(k) biosimilar regulatory pathway,” Marc Forth, AEON’s President and Chief Executive Officer, said in the press release. “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 US market for all of BOTOX’s currently approved and future therapeutic indications under a single approval.”

As previously announced, AEON expects it will need to conduct, subject to securing funding, a Phase 3 program to compare ABP-450 (prabotulinumtoxinA) with BOTOX® (onabotulinumtoxinA) as the reference product. Under the 351(k) regulatory framework, comparative clinical studies are only required when it is necessary to address any residual uncertainty regarding biosimilarity following a comparative analytical assessment (CAA). The necessity of any specific comparative clinical studies will be determined after the FDA has reviewed the results from the CAA, which AEON currently anticipates in 2025.