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

Brin MF, James C, Maltman J - Biologics (2014)

Bottom Line: These differences result in a specific set of interactions between each BoNTA product and the tissue injected.Differentiation through regulatory approvals provides a measure of confidence in safety and efficacy at the specified doses for each approved indication.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.

View Article: PubMed Central - PubMed

Affiliation: Allergan, Inc., Irvine, CA, USA ; Department of Neurology, University of California, Irvine, CA, USA.

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.

No MeSH data available.


Related in: MedlinePlus

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.
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f2-btt-8-227: 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.

Mentions: Publications of the three main BoNTA products’ basic pharmacologic properties, clinical efficacy, and safety, coupled with manufacturing quality standards, lend confidence to these therapeutics. Mohindru et al presented data at the 2013 Second International Congress on Treatment of Dystonia in Hannover, Germany, documenting that, as a class, BoNTA products have been extensively researched (onabotulinumtoxinA cited in 2,838 clinical and nonclinical articles, abobotulinumtoxinA cited in 987 clinical and nonclinical articles, and incobotulinumtoxinA, cited in 87 clinical and nonclinical articles).110 Regulatory approvals and published peer-reviewed studies, including studies on mechanism of action, further differentiate BoNTA products beyond the differences conferred during the manufacturing and formulation processes (Figure 2).


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

Brin MF, James C, Maltman J - Biologics (2014)

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.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4199839&req=5

f2-btt-8-227: 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.
Mentions: Publications of the three main BoNTA products’ basic pharmacologic properties, clinical efficacy, and safety, coupled with manufacturing quality standards, lend confidence to these therapeutics. Mohindru et al presented data at the 2013 Second International Congress on Treatment of Dystonia in Hannover, Germany, documenting that, as a class, BoNTA products have been extensively researched (onabotulinumtoxinA cited in 2,838 clinical and nonclinical articles, abobotulinumtoxinA cited in 987 clinical and nonclinical articles, and incobotulinumtoxinA, cited in 87 clinical and nonclinical articles).110 Regulatory approvals and published peer-reviewed studies, including studies on mechanism of action, further differentiate BoNTA products beyond the differences conferred during the manufacturing and formulation processes (Figure 2).

Bottom Line: These differences result in a specific set of interactions between each BoNTA product and the tissue injected.Differentiation through regulatory approvals provides a measure of confidence in safety and efficacy at the specified doses for each approved indication.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.

View Article: PubMed Central - PubMed

Affiliation: Allergan, Inc., Irvine, CA, USA ; Department of Neurology, University of California, Irvine, CA, USA.

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.

No MeSH data available.


Related in: MedlinePlus