Johanna Andrea García Cortes, MSc, Colombia

Transcription

1 GaBI Scientific Meetings 15 August 2017, Hiilton Bogotá, Colombia Second Colombian Scientific Meeting on Quality Assessment of BIOSIMILARS/SIMILAR BIOTHERAPEUTIC PRODUCTS Johanna Andrea García Cortes, MSc, Colombia Professional Specialist, Medicamentos y Productos Biológicos, Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Colombia

2 GaBI Scientific Meetings 15 August 2017, Hiilton Bogotá, Colombia Second Colombian Scientific Meeting on Quality Assessment of BIOSIMILARS/SIMILAR BIOTHERAPEUTIC PRODUCTS Biosimilars regulations in Colombia Johanna Andrea García Cortes, MSc 15 August 2017

3 Biosimilar Regulation in Colombia

4 CONTENTS Current Regulation (Before Implementation) Changes in the Study Process due to Implementation Full Case File Approach Comparability Approach Abbreviated Comparability Approach

5 INSTITUTIONAL CHART Board Of Directors General Direction Dr Javier Guzman Medicines and Biological Products Direction Dr Francisco Sierra

6 MARKETING AUTHORIZATION PROCESS TODAY Pharmacological Evaluation Legal and Quality and process Assessment Laboratory test ( Batch Release)

7 Regulatory timeframe Decree Sep, Decree preparation and drafting: MOH - Invima Debate and consultation (First round) Debate and consultation (second round) Debate and consultation (third round) Debate and consultation(fourth round) Debate and consultation (fifth round) Inmunogenicity guideline Stability guideline GMP guideline 3 Jan, Jan, Jan Feb Feb May May Feb Feb Jun Jun Jun 2014 Sep Mar 2017 Sep Aug Sep Dec 2015

8 CHANGES IN THE STUDY PROCESS DUE TO IMPLEMENTATION Step 1:Pharmacologycal Assessment Efficacy and Security Pharmacological Application Pharmacological Submission Quality and Process Pharmacovigilance Group review Quality Control Decision Making Process Marketing Authorization Submission Step 2 Marketing Authorization Application Public report

9 3 PATHWAYS FOR EVALUATION FULL DOSSIER CASE COMPARABILITY ABBREVIATED COMPARABILITY Manufacturing Process and Production Place Expression System Biological Identity Potency and Purity Physicochemical Properties Biological Activity Immunogenicity

10 COMPLETE DOSSIER APPROACH Module 1 Administrative Module 2 Summary Module 3 Quality Module 4 Non Clinical Designed in Biologicals for: 1. New Molecules, New Developments Module 5 Clinical full dossier ICH Topic M 4 Q Common Technical Document for the Registration of Pharmaceuticals for Human Use

11 Comparability Approach Designed in Biologicals for: 1. Patent-expired molecules 2. Molecules that are compared against a reference product Module 1 ADMINISTRATIVE Module 2 Summary Module 3 Quality + Comparability Full Module 4 Non Clinical + Comparability Module 5 Clinical Reduce + Comparability

12 EMA AND FDA: Abbreviated comparability EMA CHMP/437/04 Rev

13 Products Containing Active Pharmaceutical Ingredients Which are: - Sufficiently Characterized ABBREVIATED COMPARABILITY APPROACH Which Products Can Choose the Abbreviate Comparability Approach - Those Which have a Safety and Efficacy Well-defined Profile and are Well-documented - Those Which have Strong Clinical Experience - Those Which have Strong Pharmacovigilance

14 ABBREVIATED COMPARABILITY APPROACH 2. Comparability way 3. Abbreviated comparability Module 1 Module 2 Module 3 Module 4 Module 5 Administrative Summary Quality + Comparability Non-Clinical Reduced + Comparability Clinical (PK/PD)

15 DIFFERENCES AMONG THE THREE APPROACHES COMPLETED COMPARABILITY ABREV.COMPARABILITY Module 1 Module 1 Module 1 Module 2 Module 2 Module 2 Module 3 Quality Full Module 3 Quality + Comparability Module 3 Quality + Comparability Module 4 Non Clinical Full Module 4 Non-Clinical+ Comparability Module 4 Non-Clinical Reduced + Comparability Module 5 Clinical Full Module 5 Clinical Reduce + Comparability Module 5 Clinical (PK/PD) + Comparability

16 Thank You Carrera Bogotá - Colombia Teléfono conmutador: