AEON Biopharma Holds Meeting With FDA for Botox Biosimilar

Dow Jones

Jan 22

By Kelly Cloonan

AEON Biopharma met with the Food and Drug Administration regarding its biosimilar for Botox and plans to comment on the meeting after receiving official minutes.

The biopharmaceutical company said Wednesday it held a scheduled BPD Type 2a meeting, which is meant to focus specifically on a narrow set of issues. The meeting aimed to review AEON's analytical development plan and initial data supporting biosimilarity, AEON said in November.

The company expects the minutes to inform its next steps for the development of ABP-450, Chief Executive Rob Bancroft said. It is seeking accelerated and full-label U.S. market entry for ABP-450.

"The completion of our BPD Type 2a meeting with FDA represents an important procedural milestone," Bancroft said.

Write to Kelly Cloonan at kelly.cloonan@wsj.com

(END) Dow Jones Newswires

January 21, 2026 16:46 ET (21:46 GMT)

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The meeting aimed to review AEON's analytical development plan and initial data supporting biosimilarity, AEON said in November. \n\n\n  The company expects the minutes to inform its next steps for the development of ABP-450, Chief Executive Rob Bancroft said. It is seeking accelerated and full-label U.S. market entry for ABP-450. \n\n\n  \"The completion of our BPD Type 2a meeting with FDA represents an important procedural milestone,\" Bancroft said. \n\n\n \n\n\n  Write to Kelly Cloonan at kelly.cloonan@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  January 21, 2026 16:46 ET (21:46 GMT)\n\n\n  Copyright (c) 2026 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}