AEON Biopharma Announces Positive Outcome from FDA Biosimilar Advisory Meeting
AEON Biopharma (NYSE: AEON) announced a positive outcome from its FDA Biosimilar Advisory Meeting for ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX® (onabotulinumtoxinA). The company is aligned with the FDA on the 351(k) regulatory pathway for approval. Key points include:
1. Comparative analytical studies are expected to start in Q4 2024.
2. A Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA is planned for 2025 to review results and confirm the proposed study package.
3. AEON aims to bring prabotulinumtoxinA to the U.S. market for all of BOTOX's approved and future therapeutic indications under a single approval.
4. The company anticipates conducting a Phase 3 program, subject to funding, to compare ABP-450 with BOTOX®.
AEON Biopharma (NYSE: AEON) ha annunciato un esito positivo dal suo incontro consultivo con l'FDA riguardo all'ABP-450 (prabotulinumtoxinA) come biosimilare di BOTOX® (onabotulinumtoxinA). L'azienda è in linea con l'FDA sul percorso normativo 351(k) per l'approvazione. I punti chiave includono:
1. Gli studi analitici comparativi dovrebbero iniziare nel Q4 2024.
2. È previsto un incontro di tipo 2 sulla Sviluppo di Prodotti Biologici Biosimilari (BPD) con l'FDA per 2025 per rivedere i risultati e confermare il pacchetto di studio proposto.
3. AEON punta a portare prabotulinumtoxinA nel mercato statunitense per tutte le indicazioni terapeutiche approvate e future di BOTOX con un'unica approvazione.
4. L'azienda prevede di condurre un programma di Fase 3, soggetto a finanziamento, per confrontare ABP-450 con BOTOX®.
AEON Biopharma (NYSE: AEON) anunció un resultado positivo de su reunión consultiva con la FDA sobre el ABP-450 (prabotulinumtoxinA) como biosimilar de BOTOX® (onabotulinumtoxinA). La compañía está alineada con la FDA en la vía regulatoria 351(k) para la aprobación. Los puntos clave incluyen:
1. Se espera que los estudios analíticos comparativos comiencen en Q4 2024.
2. Está planeada una reunión de tipo 2 sobre el Desarrollo de Productos Biológicos Biosimilares (BPD) con la FDA para 2025 para revisar los resultados y confirmar el paquete de estudio propuesto.
3. AEON tiene como objetivo llevar prabotulinumtoxinA al mercado de EE. UU. para todas las indicaciones terapéuticas aprobadas y futuras de BOTOX bajo una única aprobación.
4. La compañía anticipa llevar a cabo un programa de Fase 3, sujeto a financiamiento, para comparar ABP-450 con BOTOX®.
AEON Biopharma (NYSE: AEON)는 ABP-450 (prabotulinumtoxinA)를 BOTOX® (onabotulinumtoxinA)의 바이오시밀러로 간주하여 FDA 자문 회의에서 긍정적인 결과를 발표했습니다. 회사는 승인을 위한 FDA와 351(k) 규제 경로에 맞추어 움직이고 있습니다. 주요 내용은 다음과 같습니다:
1. 비교 분석 연구는 2024년 4분기에 시작될 예정입니다.
2. FDA와의 바이오시밀러 생물학적 제품 개발(BPD) type 2 회의가 2025년에 계획되어 있으며 결과를 검토하고 제안된 연구 패키지를 확인할 예정입니다.
3. AEON은 모든 BOTOX의 승인된 및 향후 치료 적응증에 대해 단일 승인을 통해 prabotulinumtoxinA를 미국 시장에 출시할 계획입니다.
4. 회사는 자금 조달이 조건인 Phase 3 프로그램을 수행하여 ABP-450과 BOTOX®를 비교할 것으로 예상하고 있습니다.
AEON Biopharma (NYSE: AEON) a annoncé un résultat positif de sa réunion consultative avec la FDA concernant l'ABP-450 (prabotulinumtoxinA) en tant que biosimilaire du BOTOX® (onabotulinumtoxinA). L'entreprise est alignée avec la FDA sur la voie réglementaire 351(k) pour l'approbation. Les points clés incluent :
1. Les études analytiques comparatives devraient débuter au T4 2024.
2. Une réunion de type 2 sur le Développement de Produits Biologiques Biosimilaires (BPD) avec la FDA est prévue pour 2025 afin d'examiner les résultats et de confirmer le paquet d'étude proposé.
3. AEON vise à introduire le prabotulinumtoxinA sur le marché américain pour toutes les indications thérapeutiques approuvées et futures de BOTOX sous une seule approbation.
4. L'entreprise prévoit de mener un programme de Phase 3, sous réserve de financement, pour comparer l'ABP-450 avec le BOTOX®.
AEON Biopharma (NYSE: AEON) hat ein positives Ergebnis aus dem FDA-Biosimilar-Beratungstreffen für ABP-450 (prabotulinumtoxinA) als Biosimilar zu BOTOX® (onabotulinumtoxinA) bekannt gegeben. Das Unternehmen ist mit der FDA beim regulatorischen Weg 351(k) abgestimmt für die Genehmigung. Wichtige Punkte sind:
1. Vergleichende analytische Studien sollen im Q4 2024 beginnen.
2. Ein Biosimilar Biological Product Development (BPD) Typ 2 Treffen mit der FDA ist für 2025 geplant, um die Ergebnisse zu überprüfen und das vorgeschlagene Studienpaket zu bestätigen.
3. AEON plant, prabotulinumtoxinA für alle genehmigten und zukünftigen therapeutischen Indikationen von BOTOX auf den US-Markt zu bringen, unter einer einzigen Genehmigung.
4. Das Unternehmen beabsichtigt, ein Phase 3-Programm durchzuführen, das von der Finanzierung abhängt, um ABP-450 mit BOTOX® zu vergleichen.
- Alignment with FDA on 351(k) regulatory pathway for ABP-450 biosimilar approval
- Clear development path established with comparative analytical studies starting Q4 2024
- Potential for single approval covering all BOTOX's current and future therapeutic indications
- Opportunity to enter the U.S. market with a biosimilar to a well-established product (BOTOX)
- Need for additional funding to conduct required Phase 3 program
- Uncertainty regarding the necessity of comparative clinical studies pending FDA review of analytical assessment
- Extended timeline for potential market entry, with key meetings and studies planned through 2025
Insights
This news is highly significant for AEON Biopharma and the broader botulinum toxin market. The FDA's alignment on the 351(k) biosimilar pathway for ABP-450 could potentially streamline the approval process, reducing time and costs compared to a traditional new drug application. Key points:
- Comparative analytical studies planned for Q4 2024 are important for demonstrating biosimilarity to BOTOX®
- The 2025 BPD Type 2 meeting will be pivotal in determining the extent of clinical trials required
- If successful, this approach could allow AEON to target all of BOTOX's approved indications with a single approval
This strategy could significantly expand AEON's market potential, as BOTOX® generated over
The FDA's receptiveness to AEON's 351(k) biosimilar approach for ABP-450 is a positive regulatory signal. Key regulatory considerations:
- The 351(k) pathway can be faster and less costly than traditional approval routes
- Comparative Analytical Assessment (CAA) is crucial; positive results could reduce clinical trial requirements
- The FDA's flexibility on clinical studies post-CAA is noteworthy, potentially saving significant resources
However, challenges remain. The company must demonstrate high analytical similarity to BOTOX®, a complex biological product. Any discrepancies could lead to more extensive clinical trial requirements. The 2025 BPD Type 2 meeting will be critical in determining the regulatory path forward. While promising, investors should be aware that biosimilar development still carries regulatory risks and uncertainties.
– 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.
The Company believes it is aligned with the FDA on key requirements, including additional analytical studies to be completed to fulfill the standard regulatory requirements for a comparative analytical assessment (CAA). The Company is actively planning comparative analytical studies, which are expected to commence in Q4 2024. A Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA is planned for 2025 to discuss the outcome from these studies and determine the next steps in development, including a potential comparative clinical program.
“We are encouraged by the outcome from the recent FDA meeting and the opportunity to advance our development of prabotulinumtoxinA utilizing the 351(k) biosimilar regulatory pathway,” commented Marc Forth, AEON’s President and Chief Executive Officer. “We now have a clear path forward and plan to initiate analytical studies in Q4 2024. This biosimilar approach could potentially allow us to bring prabotulinumtoxinA to the U.S. market for all of BOTOX’s currently approved and future therapeutic indications under a single approval.”
As previously announced, the Company expects it will need to conduct, subject to securing funding, a Phase 3 program to compare ABP-450 (prabotulinumtoxinA) with BOTOX® (onabotulinumtoxinA) as the reference product. Under the 351(k) regulatory framework, comparative clinical studies are only required when it is necessary to address any residual uncertainty regarding biosimilarity following a comparative analytical assessment (CAA). The necessity of any specific comparative clinical studies will be determined after the FDA has reviewed the results from the CAA, which AEON currently anticipates in 2025.
About AEON Biopharma
AEON is a clinical stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, or ABP-450, for debilitating medical conditions, with an initial focus on the neurosciences market. ABP-450 is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus under the name Jeuveau. ABP-450 is manufactured by Daewoong in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, Health Canada and European Medicines Agency. The product is approved as a biosimilar in Mexico and India. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. The Company has built a highly experienced management team with specific experience in biopharmaceutical and botulinum toxin development and commercialization. To learn more about AEON, visit www.aeonbiopharma.com.
Forward-Looking Statements
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON’s future financial or operating performance. For example, statements regarding meetings with the FDA, the timing of analytical studies and a potential Phase 3 comparative program, the securing of additional funding, the translation of clinical trial results into support for a BLA filing, and potential determination that ABP-450 is highly similar to the reference product for currently approved and future therapeutic indications are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "plan", "possible", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements.
These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the outcome of any legal proceedings that may be instituted against AEON or others; (ii) AEON’s future capital requirements; (iii) AEON’s ability to raise financing in the future; (iv) AEON’s ability to continue to meet continued stock exchange listing standards; (v) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; and (vi) other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s filings with the Securities and Exchange Commission (the "SEC"), which are available on the SEC’s website at www.sec.gov.
Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements.
Source: AEON Biopharma
FAQ
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