4.2 Article

Comparing two botulinum toxin type A formulations using manufacturers' product summaries

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WILEY
DOI: 10.1111/j.1365-2710.2007.00835.x

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bioequivalence; biologicals; botulinum toxin type A; safety margin; Summary of Product Characteristics; therapeutic margin

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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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