AEON Biopharma (NYSE: AEON) has announced a positive outcome from its FDA Biosimilar Advisory Meeting regarding ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX® (onabotulinumtoxinA). This alignment with the FDA on the 351(k) regulatory pathway marks a significant step forward in AEON's efforts to introduce a biosimilar botulinum toxin to the U.S. market.
The company anticipates initiating comparative analytical studies in Q4 2024. Following these studies, AEON plans to hold a Biosimilar Biological Product Development (BPD) Type 2 meeting with the FDA in 2025 to review the analytical results and confirm the proposed study package. AEON's strategic goal is to secure a single approval that covers all of BOTOX's currently approved and future therapeutic indications.
Marc Forth, AEON’s President and Chief Executive Officer, stated, “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. 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 U.S. market for all of BOTOX’s currently approved and future therapeutic indications under a single approval.”
Clinical and Regulatory Strategy
AEON Biopharma is pursuing the 351(k) biosimilar pathway, which is designed for products that are demonstrated to be highly similar to an already-approved reference product. This pathway can potentially expedite the approval process compared to traditional new drug applications. A key component of this approach is the comparative analytical assessment (CAA), which involves rigorous testing to demonstrate biosimilarity at the molecular level.
The company expects that it will need to conduct a Phase 3 program to compare ABP-450 with BOTOX® as the reference product, contingent upon securing funding. 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.
Market Opportunity
BOTOX® generated over $4.8 billion in revenue in 2022, highlighting the significant market opportunity for a biosimilar product. AEON's strategy to target all approved and future therapeutic indications of BOTOX® with a single approval could substantially expand its market potential, if successful.
About ABP-450
ABP-450 (prabotulinumtoxinA) is AEON's proprietary botulinum toxin complex. It is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus under the name Jeuveau. ABP-450 is manufactured by Daewoong in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, Health Canada and European Medicines Agency. The product is approved as a biosimilar in Mexico and India. AEON has 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.
