{"id":1007017,"date":"2026-09-30T08:06:15","date_gmt":"2026-09-30T12:06:15","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/aeon-biopharma-fda-type-2b-meeting-feedback-clarifies-biosimilar-development-plan-for-abp-450\/"},"modified":"2026-09-30T08:06:15","modified_gmt":"2026-09-30T12:06:15","slug":"aeon-biopharma-fda-type-2b-meeting-feedback-clarifies-biosimilar-development-plan-for-abp-450","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/aeon-biopharma-fda-type-2b-meeting-feedback-clarifies-biosimilar-development-plan-for-abp-450\/","title":{"rendered":"AEON Biopharma FDA Type 2b Meeting Feedback Clarifies Biosimilar Development Plan for ABP-450"},"content":{"rendered":"
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\n FDA indicated previously completed ABP-450 head-to-head studies versus BOTOX\u00ae may be submitted as supportive evidence; AEON expects to advance the required scientific bridging work<\/em>\n <\/p>\n

\n AEON plans to submit an IND for CMAP pharmacodynamic study in the fourth quarter of 2026<\/em>\n <\/p>\n

\n AEON plans to leverage its analytical, pharmacodynamic, and existing comparative human evidence to support a potential streamlined development path<\/em>\n <\/p>\n

ALISO VIEJO, Calif., Sept. 30, 2026 (GLOBE NEWSWIRE) — AEON Biopharma, Inc. (\u201cAEON\u201d or the \u201cCompany\u201d) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 as a biosimilar to BOTOX\u00ae (onabotulinumtoxinA) for therapeutic use to achieve full-label U.S. market entry, today announced receipt of the official minutes from its Biosimilar Biological Product Development (\u201cBPD\u201d) Type 2b meeting held with the U.S. Food and Drug Administration (\u201cFDA\u201d or the \u201cAgency\u201d) regarding ABP-450\u2019s development pathway.<\/p>\n

\u201cThe Type 2b meeting feedback provides greater clarity on the development pathway for ABP-450 and, consistent with FDA’s recent biosimilar guidance, supports a potentially more efficient clinical development program,\u201d said Rob Bancroft, President and Chief Executive Officer of AEON. \u201cOur strategy is to bring together the most sensitive, complementary and relevant evidence available, including our analytical program, comparative human pharmacodynamic data and the substantial comparative human experience already generated with ABP-450. Where those lines of evidence converge, we believe they may support proceeding without a standalone comparative efficacy study or narrowing the clinical work required, improving the capital and time efficiency with which we advance ABP-450 toward its potential commercial opportunity. We are excited to embark on this next phase of ABP-450\u2019s development and look forward to submitting the IND for the CMAP study later this year.\u201d<\/p>\n

The Type 2b meeting provided feedback across the following components of AEON\u2019s development plan:<\/p>\n

\n Comparative Pharmacodynamic Study<\/strong>\n <\/p>\n

AEON proposed a two-stage design for a comparative pharmacodynamic (\u201cPD\u201d) study using Compound Muscle Action Potential (\u201cCMAP\u201d) measurement in the extensor digitorum brevis muscle consisting of an initial dose-finding stage followed by a comparative PD evaluation. The FDA agreed in principle with the initial dose-finding stage which will be conducted in healthy volunteers. The FDA also provided recommendations intended to strengthen the study\u2019s ability to demonstrate assay sensitivity. AEON intends to incorporate the FDA\u2019s feedback and advance the study under an investigational new drug application (\u201cIND\u201d), which the Company expects to submit in the fourth quarter of 2026.<\/p>\n

In a biosimilar development program, PD measures are tests that evaluate the biological, molecular, and physiological effects a drug has on the body to confirm that the biosimilar interacts with its intended therapeutic target in a similar way as the original reference biologic. PD evidence is particularly important for a botulinum toxin, which acts locally and is not present at reliably measurable systemic concentrations following therapeutic administration, making conventional comparative pharmacokinetic studies infeasible.<\/p>\n

\n Previously Completed Comparative Studies<\/strong>\n <\/p>\n

The FDA indicated that comparative clinical studies previously conducted by Daewoong Pharmaceutical across several indications including studies in blepharospasm, upper limb spasticity, glabellar lines and lateral canthal lines, can be submitted for consideration as supportive evidence, subject to appropriate scientific bridging to U.S.-licensed BOTOX\u00ae and between the ABP-450 drug product used in each study and ABP-450 as currently manufactured. Blepharospasm and upper limb spasticity are therapeutic indications included on the U.S. BOTOX\u00ae label, while glabellar lines and lateral canthal lines are included on the BOTOX Cosmetic\u00ae label.<\/p>\n

These studies evaluated ABP-450 relative to BOTOX\u00ae across a range of indications, doses and muscles, with each study meeting its pre-specified non-inferiority endpoint. AEON intends to complete the scientific bridging work necessary to support their consideration within the totality of evidence for ABP-450. If appropriately bridged, AEON believes these studies could complement the analytical and PD programs by providing additional comparative human evidence supportive of biosimilarity.<\/p>\n

\n Comparative Clinical Study Considerations<\/strong>\n <\/p>\n

The FDA\u2019s scientific approach to biosimilar development has continued to evolve toward greater reliance on evidence that is most sensitive to detecting meaningful differences between a proposed biosimilar and its reference product. In October 2025, the FDA issued draft guidance recognizing that traditional comparative efficacy studies (\u201cCES\u201d) generally have limited sensitivity to detect product differences and may not be necessary where more sensitive evidence sufficiently supports a determination of biosimilarity. The guidance reflects the FDA\u2019s growing experience that traditional clinical efficacy endpoints may provide limited additional discriminatory information in biosimilar development.<\/p>\n

Consistent with this evolving framework, during the Type 2b meeting, the FDA emphasized that, if additional clinical evidence is ultimately needed, such evidence should be sufficiently sensitive to detect a meaningful difference between the products, if one exists. The FDA also indicated that more sensitive measures of biological activity, rather than traditional clinical efficacy endpoints, could be considered and that the design of any additional clinical study should be guided by the specific residual uncertainty remaining following completion of the comparative analytical assessment (\u201cCAA\u201d). Accordingly, AEON does not intend to initiate a CES at this time and will first evaluate the totality of its analytical, pharmacodynamic and comparative human evidence to determine whether additional clinical evidence is scientifically necessary and, if so, the most appropriate approach to address any remaining residual uncertainty.<\/p>\n

\n Indication-Specific Considerations<\/strong>\n <\/p>\n

The FDA feedback also addressed indication-specific considerations, including chronic migraine. During the meeting, the FDA invited the Company to provide analyses supporting the rationale for the outcome of the previously conducted Phase 2 study for the prevention of migraine headache, which the Company intends to complete and provide to the FDA as part of its 351(k) Biologics License Application (\u201cBLA\u201d) submission.<\/p>\n

\n Comparative Analytical Assessment<\/strong>\n <\/p>\n

The CAA is the scientific foundation of development under the 351(k) pathway and provides a sensitive means of identifying potential structural and functional differences between a proposed biosimilar and its reference product. AEON is conducting a broad CAA of ABP-450 and U.S.-licensed BOTOX\u00ae across structural, physicochemical and functional attributes. The Company recently reported progress across multiple dimensions of that program, including expanded primary-sequence characterization, confirmation of critical disulfide-bond architecture, and pilot forced-degradation results demonstrating highly similar degradation behavior between ABP-450 and BOTOX\u00ae under thermal and oxidative stress conditions.\u00a0<\/p>\n

\n Next Steps: Converging Evidence<\/strong>\n <\/p>\n

AEON\u2019s next phase of development will integrate its maturing comparative analytical foundation with multiple independent and complementary lines of evidence, including human PD evidence, existing comparative human evidence scientifically bridged to the biosimilar program, and targeted evidence addressing indication-specific questions. The Company intends to leverage the convergence of these evidence streams to build a scientifically supported case whereby a standalone CES may not further inform a determination of biosimilarity. AEON plans to return to the FDA in 2027 with its integrated evidence package.<\/p>\n

\n Anticipated milestones for ABP-450\u2019s development program include:<\/strong>\n <\/p>\n