Botulinum toxin type A products are not interchangeable: a review of the evidence

Abstract

Botulinum toxin type A (BoNTA) products are injectable biologic medications derived from Clostridium botulinum bacteria. Several different BoNTA products are marketed in various countries, and they are not interchangeable. Differences between products include manufacturing processes, formulations, and the assay methods used to determine units of biological activity. These differences result in a specific set of interactions between each BoNTA product and the tissue injected. Consequently, the products show differences in their in vivo profiles, including preclinical dose response curves and clinical dosing, efficacy, duration, and safety/adverse events. Most, but not all, published studies document these differences, suggesting that individual BoNTA products act differently depending on experimental and clinical conditions, and these differences may not always be predictable. Differentiation through regulatory approvals provides a measure of confidence in safety and efficacy at the specified doses for each approved indication. Moreover, the products differ in the amount of study to which they have been subjected, as evidenced by the number of publications in the peer-reviewed literature and the quantity and quality of clinical studies. Given that BoNTAs are potent biological products that meet important clinical needs, it is critical to recognize that their dosing and product performance are not interchangeable and each product should be used according to manufacturer guidelines.

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Keywords:

• onabotulinumtoxinA
• abobotulinumtoxinA
• incobotulinumtoxinA
• glabellar lines
• non-interchangeability

Acknowledgments

Writing and editorial assistance was provided to the authors by MaryAnn Chapman, PhD and funded by Allergan Inc., Irvine, CA. The authors also acknowledge the contributions of Conor Gallagher, PhD to critical review of the manuscript.

Disclosure

The authors of this manuscript are employees of Allergan, Inc., the manufacturers of onabotulinumtoxinA. The authors report no other conflicts of interest in this work.