AEON Biopharma Says Is Aligned With FDA On Next Steps For 351(k) Regulatory Pathway To Approval For ABP-450 As A Biosimilar Utilizing BOTOX As The Reference Product
Portfolio Pulse from Benzinga Newsdesk
AEON Biopharma has announced alignment with the FDA on the next steps for the 351(k) regulatory pathway to approve ABP-450 as a biosimilar, using BOTOX as the reference product.
September 30, 2024 | 12:05 pm
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AEON Biopharma is aligned with the FDA on the regulatory pathway for ABP-450, a biosimilar to BOTOX, which could lead to its approval.
The alignment with the FDA on the regulatory pathway is a significant step towards the approval of ABP-450, which could enhance AEON's product offerings and market position.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100