Pharmacokinetic (PK) Comparability for Biosimilars: Anvisa Perspective · Pharmacokinetic (PK)...
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Agência Nacional
de Vigilância Sanitária www.anvisa.gov.br
Pharmacokinetic (PK) Comparability for Biosimilars: Anvisa Perspective
Gustavo Mendes Lima Santos Coordinator of Therapeutic Equivalence
General Office of Medicines Anvisa
Bio Latin America Conference São Paulo. 27th October 2016
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Agência Nacional
de Vigilância Sanitária www.anvisa.gov.br
Clarification Note n. 002/2015
• PK Studies for Biosimilars:
• Evidence of similarity;
• Needed for conclusion of the assessment of application.
• Should be submitted in digital format simultaneously with the application by the code 10846.
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Agência Nacional
de Vigilância Sanitária www.anvisa.gov.br
Comparative Pharmacokinetic Studies
Source: http://www.bpac.org.nz/BPJ/2007/March/bioequiv.aspx
Oral Absorption
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Agência Nacional
de Vigilância Sanitária www.anvisa.gov.br
Comparative Pharmacokinetic Studies
Source: Wolfgang F. Richter, and Björn Jacobsen Drug Metab Dispos 2014;42:1881-1889
Intravenous (IV) and Subcutaneous (SC) Absorption
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Agência Nacional
de Vigilância Sanitária www.anvisa.gov.br
Comparative Pharmacokinetic Studies
Source: https://www.boomer.org/c/p4/c15/c1504.html
Multiple Oral Administration
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Agência Nacional
de Vigilância Sanitária www.anvisa.gov.br
Clarification Note n. 002/2015
• Documentation based on RE nº 895/2003:
• General Information (product, CRO, signature list);
• Clinical report (study design, administration, population, hospilatization);
• Bioanalytical report (methodology, validation, calculated concentrations, procedures);
• Statistical report (PK and statistical analysis, data according to Technical Note n. 04/2016).
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Agência Nacional
de Vigilância Sanitária www.anvisa.gov.br
Clarification Note n. 002/2015
• Recomendations for Design of Comparative PK Studies for Biosimilars:
• Justifications for inclusion of patients or healthy subjects;
• Intra and Inter-Subject variability for determination of number
of subjects;
• PK linearity for selection of dose;
• Approval of IEC.
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Agência Nacional
de Vigilância Sanitária www.anvisa.gov.br
Clarification Note n. 002/2015
• Recomendations for Design of Comparative PK Studies for Biosimilars:
• Bioanalytic Method Validation based on RDC n. 27/2012;
• For each PK parameter: log-transformed with each individual
value, SD, CV and ANOVA
• For AUC0-t and Cmax: 90% of Confidence Interval.
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Agência Nacional
de Vigilância Sanitária www.anvisa.gov.br
Clarification Note n. 002/2015
• Recomendations for Design of Comparative PK Studies for Biosimilars:
• Bioanalytic Method Validation based on RDC n. 27/2012;
• For each PK parameter: log-transformed with each individual
value, SD, CV and ANOVA;
• For AUC0-t and Cmax: 90% of Confidence Interval;
• Similarity criteria: 90% GMR between 0.8 and 1,25.
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Agência Nacional
de Vigilância Sanitária www.anvisa.gov.br
Technical Note n. 118/2016
• Comparative PK Studies for Biosimilars should be submitted simultaneously with the application to DDCM:
Source: http://www.themednote.com/2011/07/10/pharmacodynamics-vs-pharmacokinetics/
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Agência Nacional
de Vigilância Sanitária www.anvisa.gov.br
Technical Note n. 118/2016
• Major Considerations:
• Submission code 10900;
• 45 days for the first comunication if prioritization is approved;
• If CETER assess this documents during DDCM, it isn’t necessary to submit again during biosimilar application.
Source: http://www.themednote.com/2011/07/10/pharmacodynamics-vs-pharmacokinetics/
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Agência Nacional
de Vigilância Sanitária www.anvisa.gov.br
Common queries by CETER
• Format of the Report;
• Laboratorial exams for subjects;
• Raw data and results of the bioanalytical report (validation, batch runs);
• Stability of drug in plasma;
Source: http://www.themednote.com/2011/07/10/pharmacodynamics-vs-pharmacokinetics/
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Agência Nacional
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Thank you!
Source: http://shenlinlab.com/Blog%20Topics%20html/FDA%20Law%20Blog%203%20Biosimilars.html