Clinical comparability of marketed formulations of botulinum toxin
Identifieur interne :
000A74 ( PascalFrancis/Curation );
précédent :
000A73;
suivant :
000A75
Clinical comparability of marketed formulations of botulinum toxin
Auteurs : Cristina Sampaio [
Portugal] ;
Joao Costa [
Portugal] ;
Joaquim J. Ferreira [
Portugal]
Source :
-
Movement disorders [ 0885-3185 ] ; 2004.
RBID : Pascal:04-0228361
Descripteurs français
English descriptors
Abstract
The majority of pharmaceutical products are patented in early phases of their discovery to preclude competition by similar products. Due to unusual circumstances (botulinum toxin is an unpatentable natural product and it is considered to be a biological weapon), technology know-how for botulinum toxin production was classified rather then available in the scientific community. Botulinum toxin type A was marketed in two pharmaceutical distinct formulations from competitor companies. Serendipity proved that the two formulations were not equipotent in terms of mouse units. From a regulatory point of view, differences in potency of distinct formulations are not a matter of concern because each formulation is licensed based on its own set of data. As far as the data in each case is sufficient to prove that a particular formulation is safe and efficacious at its defined dosage, a license for use can be granted. On the other hand, generation of data on comparability is the only way that clinicians and managers can ascertain which product (formulation, serotype) is most cost-effectiveness and to determine whether there are relevant differences in their safety profiles. The results of the systematic review of head-to-head randomised trials comparing BOTOX to Dysport suggest that the two formulations are not bioequivalent whatever the dose relationship. Data on comparative immunogenicity are not available. The indirect comparison of the results obtained in randomised clinical trials comparing BOTOX to placebo and Dysport to placebo support that intrinsic differences are present in the two products. It is concluded that comparative economic evaluations of different botulinum toxin formulations should move away from cost-minimization approaches based on the presumption of bioequivalence and move toward cost-effectiveness or cost-utility models.
| pA |
| A01 | 01 | 1 | | @0 0885-3185 |
|---|
| A03 | | 1 | | @0 Mov. disord. |
|---|
| A05 | | | | @2 19 |
|---|
| A06 | | | | @3 SUP8 |
|---|
| A08 | 01 | 1 | ENG | @1 Clinical comparability of marketed formulations of botulinum toxin |
|---|
| A09 | 01 | 1 | ENG | @1 Basic and Therapeutic Aspects of Neurotoxins |
|---|
| A11 | 01 | 1 | | @1 SAMPAIO (Cristina) |
|---|
| A11 | 02 | 1 | | @1 COSTA (Joao) |
|---|
| A11 | 03 | 1 | | @1 FERREIRA (Joaquim J.) |
|---|
| A12 | 01 | 1 | | @1 BIGALKE (HANS) @9 ed. |
|---|
| A12 | 02 | 1 | | @1 DRESSLER (Dirk) @9 ed. |
|---|
| A12 | 03 | 1 | | @1 JANKOVIC (Joseph) @9 ed. |
|---|
| A14 | 01 | | | @1 Laboratory of Clinical Pharmacology and Therapeutics, Lisbon School of Medicine @2 Lisbon @3 PRT @Z 1 aut. @Z 3 aut. |
|---|
| A14 | 02 | | | @1 Neurological Clinical Research Unit, Institute of Molecular Medicine, University of Lisbon @3 PRT @Z 1 aut. @Z 2 aut. @Z 3 aut. |
|---|
| A14 | 03 | | | @1 Neurology Department, Hospital de Santa Maria @2 Lisbon @3 PRT @Z 2 aut. |
|---|
| A15 | 01 | | | @1 Institute of Toxicology, Medical School of Hannover @2 Hannover @3 DEU @Z 1 aut. |
|---|
| A15 | 02 | | | @1 Department of Neurology, Rostock University @2 Rostock @3 DEU @Z 2 aut. |
|---|
| A15 | 03 | | | @1 Parkinson's Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine @2 Houston, Texas @3 USA @Z 3 aut. |
|---|
| A20 | | | | @1 129-136 |
|---|
| A21 | | | | @1 2004 |
|---|
| A23 | 01 | | | @0 ENG |
|---|
| A43 | 01 | | | @1 INIST @2 20953 @5 354000113591720180 |
|---|
| A44 | | | | @0 0000 @1 © 2004 INIST-CNRS. All rights reserved. |
|---|
| A45 | | | | @0 43 ref. |
|---|
| A47 | 01 | 1 | | @0 04-0228361 |
|---|
| A60 | | | | @1 P @2 C |
|---|
| A61 | | | | @0 A |
|---|
| A64 | 01 | 1 | | @0 Movement disorders |
|---|
| A66 | 01 | | | @0 USA |
|---|
| C01 | 01 | | ENG | @0 The majority of pharmaceutical products are patented in early phases of their discovery to preclude competition by similar products. Due to unusual circumstances (botulinum toxin is an unpatentable natural product and it is considered to be a biological weapon), technology know-how for botulinum toxin production was classified rather then available in the scientific community. Botulinum toxin type A was marketed in two pharmaceutical distinct formulations from competitor companies. Serendipity proved that the two formulations were not equipotent in terms of mouse units. From a regulatory point of view, differences in potency of distinct formulations are not a matter of concern because each formulation is licensed based on its own set of data. As far as the data in each case is sufficient to prove that a particular formulation is safe and efficacious at its defined dosage, a license for use can be granted. On the other hand, generation of data on comparability is the only way that clinicians and managers can ascertain which product (formulation, serotype) is most cost-effectiveness and to determine whether there are relevant differences in their safety profiles. The results of the systematic review of head-to-head randomised trials comparing BOTOX to Dysport suggest that the two formulations are not bioequivalent whatever the dose relationship. Data on comparative immunogenicity are not available. The indirect comparison of the results obtained in randomised clinical trials comparing BOTOX to placebo and Dysport to placebo support that intrinsic differences are present in the two products. It is concluded that comparative economic evaluations of different botulinum toxin formulations should move away from cost-minimization approaches based on the presumption of bioequivalence and move toward cost-effectiveness or cost-utility models. |
|---|
| C02 | 01 | X | | @0 002B17 |
|---|
| C03 | 01 | X | FRE | @0 Système nerveux pathologie @5 01 |
|---|
| C03 | 01 | X | ENG | @0 Nervous system diseases @5 01 |
|---|
| C03 | 01 | X | SPA | @0 Sistema nervioso patología @5 01 |
|---|
| C03 | 02 | X | FRE | @0 Formulation @5 02 |
|---|
| C03 | 02 | X | ENG | @0 Formulation @5 02 |
|---|
| C03 | 02 | X | SPA | @0 Formulación @5 02 |
|---|
| C03 | 03 | X | FRE | @0 Bontoxilysin @2 FE @2 FR @5 03 |
|---|
| C03 | 03 | X | ENG | @0 Bontoxilysin @2 FE @2 FR @5 03 |
|---|
| C03 | 03 | X | SPA | @0 Bontoxilysin @2 FE @2 FR @5 03 |
|---|
| C07 | 01 | X | FRE | @0 Metalloendopeptidases @2 FE |
|---|
| C07 | 01 | X | ENG | @0 Metalloendopeptidases @2 FE |
|---|
| C07 | 01 | X | SPA | @0 Metalloendopeptidases @2 FE |
|---|
| C07 | 02 | X | FRE | @0 Peptidases @2 FE |
|---|
| C07 | 02 | X | ENG | @0 Peptidases @2 FE |
|---|
| C07 | 02 | X | SPA | @0 Peptidases @2 FE |
|---|
| C07 | 03 | X | FRE | @0 Hydrolases @2 FE |
|---|
| C07 | 03 | X | ENG | @0 Hydrolases @2 FE |
|---|
| C07 | 03 | X | SPA | @0 Hydrolases @2 FE |
|---|
| C07 | 04 | X | FRE | @0 Enzyme @2 FE |
|---|
| C07 | 04 | X | ENG | @0 Enzyme @2 FE |
|---|
| C07 | 04 | X | SPA | @0 Enzima @2 FE |
|---|
| N21 | | | | @1 145 |
|---|
| N82 | | | | @1 OTO |
|---|
|
|---|
| pR |
| A30 | 01 | 1 | ENG | @1 Toxins 2002. Conference @3 Hannover DEU @4 2002 |
|---|
|
|---|
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Le document en format XML
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<sZ>3 aut.</sZ>
</inist:fA14><country>Portugal</country>
</affiliation><series><title level="j" type="main">Movement disorders</title>
<title level="j" type="abbreviated">Mov. disord.</title>
<idno type="ISSN">0885-3185</idno>
<imprint><date when="2004">2004</date>
</imprint><seriesStmt><title level="j" type="main">Movement disorders</title>
<title level="j" type="abbreviated">Mov. disord.</title>
<idno type="ISSN">0885-3185</idno>
</seriesStmt><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Bontoxilysin</term>
<term>Formulation</term>
<term>Nervous system diseases</term>
</keywords><keywords scheme="Pascal" xml:lang="fr"><term>Système nerveux pathologie</term>
<term>Formulation</term>
<term>Bontoxilysin</term>
</keywords><front><div type="abstract" xml:lang="en">The majority of pharmaceutical products are patented in early phases of their discovery to preclude competition by similar products. Due to unusual circumstances (botulinum toxin is an unpatentable natural product and it is considered to be a biological weapon), technology know-how for botulinum toxin production was classified rather then available in the scientific community. Botulinum toxin type A was marketed in two pharmaceutical distinct formulations from competitor companies. Serendipity proved that the two formulations were not equipotent in terms of mouse units. From a regulatory point of view, differences in potency of distinct formulations are not a matter of concern because each formulation is licensed based on its own set of data. As far as the data in each case is sufficient to prove that a particular formulation is safe and efficacious at its defined dosage, a license for use can be granted. On the other hand, generation of data on comparability is the only way that clinicians and managers can ascertain which product (formulation, serotype) is most cost-effectiveness and to determine whether there are relevant differences in their safety profiles. The results of the systematic review of head-to-head randomised trials comparing BOTOX to Dysport suggest that the two formulations are not bioequivalent whatever the dose relationship. Data on comparative immunogenicity are not available. The indirect comparison of the results obtained in randomised clinical trials comparing BOTOX to placebo and Dysport to placebo support that intrinsic differences are present in the two products. It is concluded that comparative economic evaluations of different botulinum toxin formulations should move away from cost-minimization approaches based on the presumption of bioequivalence and move toward cost-effectiveness or cost-utility models.</div>
</front><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0885-3185</s0>
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</fA06><fA08 i1="01" i2="1" l="ENG"><s1>Clinical comparability of marketed formulations of botulinum toxin</s1>
</fA08><fA09 i1="01" i2="1" l="ENG"><s1>Basic and Therapeutic Aspects of Neurotoxins</s1>
</fA09><fA11 i1="01" i2="1"><s1>SAMPAIO (Cristina)</s1>
</fA11><fA11 i1="02" i2="1"><s1>COSTA (Joao)</s1>
</fA11><fA11 i1="03" i2="1"><s1>FERREIRA (Joaquim J.)</s1>
</fA11><fA12 i1="01" i2="1"><s1>BIGALKE (HANS)</s1>
<s9>ed.</s9>
</fA12><fA12 i1="02" i2="1"><s1>DRESSLER (Dirk)</s1>
<s9>ed.</s9>
</fA12><fA12 i1="03" i2="1"><s1>JANKOVIC (Joseph)</s1>
<s9>ed.</s9>
</fA12><fA14 i1="01"><s1>Laboratory of Clinical Pharmacology and Therapeutics, Lisbon School of Medicine</s1>
<s2>Lisbon</s2>
<s3>PRT</s3>
<sZ>1 aut.</sZ>
<sZ>3 aut.</sZ>
</fA14><fA14 i1="02"><s1>Neurological Clinical Research Unit, Institute of Molecular Medicine, University of Lisbon</s1>
<s3>PRT</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
</fA14><fA14 i1="03"><s1>Neurology Department, Hospital de Santa Maria</s1>
<s2>Lisbon</s2>
<s3>PRT</s3>
<sZ>2 aut.</sZ>
</fA14><fA15 i1="01"><s1>Institute of Toxicology, Medical School of Hannover</s1>
<s2>Hannover</s2>
<s3>DEU</s3>
<sZ>1 aut.</sZ>
</fA15><fA15 i1="02"><s1>Department of Neurology, Rostock University</s1>
<s2>Rostock</s2>
<s3>DEU</s3>
<sZ>2 aut.</sZ>
</fA15><fA15 i1="03"><s1>Parkinson's Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine</s1>
<s2>Houston, Texas</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
</fA15><fA20><s1>129-136</s1>
</fA20><fA21><s1>2004</s1>
</fA21><fA23 i1="01"><s0>ENG</s0>
</fA23><fA43 i1="01"><s1>INIST</s1>
<s2>20953</s2>
<s5>354000113591720180</s5>
</fA43><fA44><s0>0000</s0>
<s1>© 2004 INIST-CNRS. All rights reserved.</s1>
</fA44><fA45><s0>43 ref.</s0>
</fA45><fA47 i1="01" i2="1"><s0>04-0228361</s0>
</fA47><fA60><s1>P</s1>
<s2>C</s2>
</fA60><fA64 i1="01" i2="1"><s0>Movement disorders</s0>
</fA64><fA66 i1="01"><s0>USA</s0>
</fA66><fC01 i1="01" l="ENG"><s0>The majority of pharmaceutical products are patented in early phases of their discovery to preclude competition by similar products. Due to unusual circumstances (botulinum toxin is an unpatentable natural product and it is considered to be a biological weapon), technology know-how for botulinum toxin production was classified rather then available in the scientific community. Botulinum toxin type A was marketed in two pharmaceutical distinct formulations from competitor companies. Serendipity proved that the two formulations were not equipotent in terms of mouse units. From a regulatory point of view, differences in potency of distinct formulations are not a matter of concern because each formulation is licensed based on its own set of data. As far as the data in each case is sufficient to prove that a particular formulation is safe and efficacious at its defined dosage, a license for use can be granted. On the other hand, generation of data on comparability is the only way that clinicians and managers can ascertain which product (formulation, serotype) is most cost-effectiveness and to determine whether there are relevant differences in their safety profiles. The results of the systematic review of head-to-head randomised trials comparing BOTOX to Dysport suggest that the two formulations are not bioequivalent whatever the dose relationship. Data on comparative immunogenicity are not available. The indirect comparison of the results obtained in randomised clinical trials comparing BOTOX to placebo and Dysport to placebo support that intrinsic differences are present in the two products. It is concluded that comparative economic evaluations of different botulinum toxin formulations should move away from cost-minimization approaches based on the presumption of bioequivalence and move toward cost-effectiveness or cost-utility models.</s0>
</fC01><fC02 i1="01" i2="X"><s0>002B17</s0>
</fC02><fC03 i1="01" i2="X" l="FRE"><s0>Système nerveux pathologie</s0>
<s5>01</s5>
</fC03><fC03 i1="01" i2="X" l="ENG"><s0>Nervous system diseases</s0>
<s5>01</s5>
</fC03><fC03 i1="01" i2="X" l="SPA"><s0>Sistema nervioso patología</s0>
<s5>01</s5>
</fC03><fC03 i1="02" i2="X" l="FRE"><s0>Formulation</s0>
<s5>02</s5>
</fC03><fC03 i1="02" i2="X" l="ENG"><s0>Formulation</s0>
<s5>02</s5>
</fC03><fC03 i1="02" i2="X" l="SPA"><s0>Formulación</s0>
<s5>02</s5>
</fC03><fC03 i1="03" i2="X" l="FRE"><s0>Bontoxilysin</s0>
<s2>FE</s2>
<s2>FR</s2>
<s5>03</s5>
</fC03><fC03 i1="03" i2="X" l="ENG"><s0>Bontoxilysin</s0>
<s2>FE</s2>
<s2>FR</s2>
<s5>03</s5>
</fC03><fC03 i1="03" i2="X" l="SPA"><s0>Bontoxilysin</s0>
<s2>FE</s2>
<s2>FR</s2>
<s5>03</s5>
</fC03><fC07 i1="01" i2="X" l="FRE"><s0>Metalloendopeptidases</s0>
<s2>FE</s2>
</fC07><fC07 i1="01" i2="X" l="ENG"><s0>Metalloendopeptidases</s0>
<s2>FE</s2>
</fC07><fC07 i1="01" i2="X" l="SPA"><s0>Metalloendopeptidases</s0>
<s2>FE</s2>
</fC07><fC07 i1="02" i2="X" l="FRE"><s0>Peptidases</s0>
<s2>FE</s2>
</fC07><fC07 i1="02" i2="X" l="ENG"><s0>Peptidases</s0>
<s2>FE</s2>
</fC07><fC07 i1="02" i2="X" l="SPA"><s0>Peptidases</s0>
<s2>FE</s2>
</fC07><fC07 i1="03" i2="X" l="FRE"><s0>Hydrolases</s0>
<s2>FE</s2>
</fC07><fC07 i1="03" i2="X" l="ENG"><s0>Hydrolases</s0>
<s2>FE</s2>
</fC07><fC07 i1="03" i2="X" l="SPA"><s0>Hydrolases</s0>
<s2>FE</s2>
</fC07><fC07 i1="04" i2="X" l="FRE"><s0>Enzyme</s0>
<s2>FE</s2>
</fC07><fC07 i1="04" i2="X" l="ENG"><s0>Enzyme</s0>
<s2>FE</s2>
</fC07><fC07 i1="04" i2="X" l="SPA"><s0>Enzima</s0>
<s2>FE</s2>
</fC07><fN21><s1>145</s1>
</fN21><fN82><s1>OTO</s1>
</fN82><pR><fA30 i1="01" i2="1" l="ENG"><s1>Toxins 2002. Conference</s1>
<s3>Hannover DEU</s3>
<s4>2002</s4>
</fA30>
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