NEWS
AEON Biopharma Announces Positive Outcome from FDA Biosimilar Advisory Meeting
– Company is aligned with the FDA on next steps for a 351(k) regulatory pathway to approval for ABP-450 (prabotulinumtoxinA) as a biosimilar utilizing BOTOX® (onabotulinumtoxinA) as the reference product –
– Comparative analytical studies anticipated to commence in Q4 2024 –
– Expect to conduct a Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA in 2025 to review the results from the analytical studies and confirm remainder of proposed study package –
IRVINE, Calif., Sept. 30, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. ("AEON" or the "Company") (NYSE:AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex under a 351(k) biosimilar pathway, today announced receipt of the formal minutes from a recent Biosimilar Initial Advisory (BIA) Meeting with the U.S. 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.
– Comparative analytical studies anticipated to commence in Q4 2024 –
– Expect to conduct a Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA in 2025 to review the results from the analytical studies and confirm remainder of proposed study package –
IRVINE, Calif., Sept. 30, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. ("AEON" or the "Company") (NYSE:AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex under a 351(k) biosimilar pathway, today announced receipt of the formal minutes from a recent Biosimilar Initial Advisory (BIA) Meeting with the U.S. 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.
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