Figures & data
Table 1 Main three BoNTA products
Table 2 Comparison of manufacturing methods for BoNTA products
Figure 1 Comparison of clinical response of two hypothetical BoNTA products.
Notes: (A) Graph showing hypothetical response at months 1 and 4 for two different products. Assessed at only month 1 and 4, the products may appear equivalent. (B) Graph showing hypothetical response at months 1, 2, 3, and 4 for the same two products. The products clearly exhibit different pharmacodynamics, as evidenced at months 2 and 3.
Table 3 Approved indicationsTable Footnotea for the main botulinum neurotoxin products available in the US and EUTable Footnoteb
Figure 2 Progressive differentiation of four hypothetical BoNTAs.
Notes: BoNTA products are biologics derived from Clostridium botulinum bacteria. For each product (denoted as example Products 1–4; not meant to correspond exactly to currently approved products), the manufacturing process, formulation, and method of determining units differ. These factors result in differences in product in vivo profiles, including preclinical dose–response curves and clinical dosing, efficacy, duration, safety/adverse events, and immunogenicity. The products are subject to further differentiation based on confidence in and knowledge of the product gained through regulatory approvals, the number and quality of clinical studies that are conducted and published in peer-reviewed journals, research into the mechanism(s) of action, long-term evidence, and anti-counterfeit measures.
Abbreviation: BoNTA, botulinum toxin type A.
Abbreviation: BoNTA, botulinum toxin type A.
