Comparing two botulinum toxin type A formulations using manufacturers' product summaries |
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Authors: | Wenzel R Jones D Borrego J A |
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Institution: | Diamond Headache Clinic Inpatient Unit, Chicago, IL 60657, USA. rich.wenzel@hotmail.com |
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Abstract: | Background and objective: Because of the unique pharmacology and clinical versatility of botulinum toxin (BoNT), particularly BoNT serotype A (BoNTA), a need exists for discussion of the current data on similarities and differences between two BoNTA products, BOTOX and Dysport. Methods: We compared the physiochemical and pharmacological properties of BOTOX and Dysport using information from the Summary of Product Characteristics (SmPC) documents from a number of countries around the world. Results and discussion: Our analysis based on the SmPC documents demonstrated distinct differences in physical characteristics, breadth of approved indications, dosing and administration, and the incidence and severity of adverse events. Conclusion: BOTOX and Dysport are not bioequivalent. Many of the differences between BOTOX and Dysport discussed within are probably related to the differences in their physical characteristics. |
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Keywords: | bioequivalence biologicals botulinum toxin type A safety margin Summary of Product Characteristics therapeutic margin |
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