Expert Interview
Examining a clinician's confidence in botox biosimilar clinical development programs
Ticker(s): VTRSV, AGN, RVNCInstitution: Private Practice
- Founder of Gold Skin Care Center, Advanced Aesthetics Medical Spa, The Laser and Rejuvenation Center and Tennessee Clinical Research Center located in Nashville, TN as well as being a Clinical Assistant Professor at Vanderbilt University School of Medicine
- Speaks on national and international fronts, focusing on dermatology issues related to the use of lasers and energy-based devices, as well as the use of fillers and toxins in aesthetic and cosmetic dermatology, lecturing in venues around the world and is a sought-after contributor to educational meetings globally.
- Author of more than 200 published scientific articles, 10 textbook chapters and the editor of a new textbook on photodynamic therapy
Based on your experience, what is the demand for botox biosimilars in the market? Other than cost, are there other advantages to the development of a botox biosimilar?
Added By: pharmaadvisorBased on your knowledge of the market/space, what is the current development status of Viatris/Revance development of their respective botox biosimilar (onabotulinumtoxinA ) and Aquavit's molecule (DTX-021 or 'Dermatox")? What are the companies' clinical development strategies (IND, 351K pathway, etc)?
Added By: pharmaadvisorFor those companies considering the 351K FDA approval pathway for botox biosimilars, how are they addressing FDA requirements to demonstrate similarity, including PK data? Are there potential problems you believe may inhibit these molecules from receiving FDA approval using the 351K pathway?
Added By: pharmaadvisorWhat indications are companies planning to pursue each of their initial botox biosimilars? In your opinion, what other clinical trials will be required to expand indications?
Added By: pharmaadvisorWhat other challenges do you anticipate companies will encounter with both approval and post-approval uptake?
Added By: pharmaadvisorAre You Interested In These Questions?
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