AEON Biopharma Announces FDA BPD Type 2a Meeting for ABP-450 on November 19 [Yahoo! Finance]
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Source: Yahoo! Finance
IRVINE, Calif., Oct. 01, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a biopharmaceutical company developing ABP-450 (prabotulinumtoxinA) as a BOTOX ® (onabotulinumtoxinA) biosimilar, today announced that the U.S. Food and Drug Administration (FDA) has scheduled a Biosimilar Biological Product Development (BPD) Type 2a meeting for ABP-450 on November 19, 2025, in line with prior guidance. The meeting will focus on AEON's analytical development plan under the 351(k) biosimilar pathway, including its framework for assessing key quality attributes and its initial similarity data. The objective of the discussion is to establish alignment with FDA on the scope and approach of the remainder of AEON's analytical analysis - a foundational step in advancing ABP-450's biosimilar development. “The FDA's scheduling of our BPD Type 2a meeting represents an important milestone in the development of ABP-450,” said Rob Bancroft, President and Chief Execut
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