Marcelo Mario Matos Moreira

Transcrição

1 CASSS LATAM 2015 Marcelo Mario Matos Moreira General-Manager of Biological Products, Blood, Tissues, Cells and Organs GGPBS Updates on Regulatory issues for Biotherapeutics Products License in Brazil August, 24 th 2015 Brazilian Health Surveillance Agency Anvisa

2 Anvisa s Mission To protect and promote public health and to intervene in the risks caused by the production and use of products regulated by health surveillance. This mission must be carried out in coordination with states, municipalities and the Federal District, according to the Brazilian Health System principles, in order to improve the quality of life of the population.

3 Areas of action Food Cosmetics Sanitizing Products Tobacco Toxicology (pesticides) Health services Drugs Medical Devices Laboratories Blood, Cells, Tissues and Organs Post-marketing surveillance Marketing control Ports, airports and frontiers International Market regulation

4 Organization chart General Office of Biologicals ACTIONS OPERATIONALIZATION TACTICAL MANAGEMENT TRANSVERSAL CONSULTING STRATEGIC ORIENTATION CONSULTIVE COUNCIL

5 Regulatory acts concerning biological products RDC 47/09 e 60/12 Package insert Law 6360/76 Decree 8.077/13 RDC 46/00 Blood products RDC 71/09, RDC 168/02 RDC 61/12 Label RDC 233/05 Allergenics RDC 81/08 Import RDC 234/05 RDC 38/10 Quality control RDC 55/10 Registration RDC 49/11 e 24/13 Post-approval RDC 323/03 Probiotics RDC 50/11 and 25/13 Stability RDC 17/10 Good Manufacturing Practices Ordinance 174/96 Antivenom serums

6 Regulatory Convergence 1. RDC 55/ Harmonized requirements for the licensing of vaccines in the Americas and Guidelines for the preparation of application

7 Guidelines Comparability exercise Guideline

8 Guidelines Heparin Guideline

9 Guidelines Interferon Alpha Guideline

10 Guidelines Guideline for Elaboration of Clinical Study Reports

11 Guidelines Future perspectives 1. Etanercept 2. Rituximab 3. Review the current guidelines

12 Transparency Drug Approval and Refusal Letters

13 Top 3 Challenges Interchangeability Extrapolation of indications International non-proprietary name or INN

14 Interchangeability EMA FDA Health Canada Anvisa Individual countries in EU have adopted varying policies US law permits FDA to designate a product as interchangeable. However, decisions about substitution by the pharmacy are governed by the state laws Health Canada doesn t declare interchangeability for biosimilars Interchangeability is under discussion. By now, Anvisa will declare interchangeability after review clinical data with this purpose

15 Interchangeability 1. A medical practice of change one medicine for another that is expected to achieve the same clinical effect; 2. It s not a requirement to license a biosimilar; 3. It s necessary to conduct clinical trials; 4. Develop international Guidelines (WHO)

16 Extrapolation of indications 1. Reflection paper on extrapolation of indication - Working group to discuss the theme and propose a reflection paper - Strong scientific justification for extrapolation of indication by companies should be emphasized in the paper

17 International non-proprietary name or INN

18 International Non-proprietary Name or INN Board Directors Resolution RDC nº 63/2012 Provides for the rules used for the Brazilian Nonproprietary Names - DCB.

19 References - Brazil, Resolution RDC n 55, December, 16th, 2010, Anvisa - Brazil, Resolution RDC n 50, September, 20th, 2011, Anvisa - Brazil, Resolution RDC n 49, September, 20th, 2011, Anvisa - Brazil, Resolution RDC n 63, December, 28th, 2012, Anvisa - Brazil, Law n 6360, September, 23th,

20 Take Home Message BIOSIMILAR SIMILAR BIOTHERAPEUTIC PRODUCTS BIOSSIMILAR BIOSIMILAR Generic Biological Biogenerics FOLLOW ON BIOLOGICS (FOB) MEDICAMENTO BIOLÓGICO SIMILAR (BIOSIMILAR) PRODUTO BIOLÓGICO OR BIOSSIMILAR SUBSEQUENT ENTRY BIOLOGICS FOLLOW-ON PROTEIN PRODUCT OR FOLLOW ON BIOLOGICS

21 Thank you Acknowledgments GPBIO and GSTCO Staff SUMED/ANVISA Contacts phone: +55(61) s: SIA Trecho 5 - Área especial 57 - Lote 200 CEP: Brasília - DF Phone: +55(61) Anvisa Atende: ouvidoria@anvisa.gov.br