Governments should actively promote pharmacovigilance of biosimilars in Latin America through a risk management approach. A risk management plan involves activities to identify, characterize, and manage medicine-related risks, including an overview of the safety profile, pharmacovigilance plan, and risk minimization plan. Experience with biologics shows that registries are important for gathering drug information. Risk management plans should be required to approve biosimilars and a Pan American registry for biologics and biosimilars should be encouraged to optimize treatment risk-benefit profiles.

1. ¿Cómo mejorar la farmacovigilancia de los biosimilares en América
Latina? Un enfoque de gestión de riesgos
Carlo V Caballero-Uribe MD
Internist Rheumatologist MD PhD (c)
Associate Profesor of Medicine
Universidad del Norte. HUN
PANLAR President
Sep 2017 #PanlarCourse

2. Disclosure
✓ EMC,
Investigacion,
Advisory Boards
✓ OliMed, Celltrion
Abbot/Lafrancol,
GSK,Jansenn ,MSD,
Pfizer, UCB, Roche

3. Agenda
• ¿What is a Risk
Management Plan ?
• Steps for a RMP
• Experience with
Biologics
• Experience in Latam
• Conclusions

5. ¿What is a Risk Management Plan?
• A RMP is a set of activities and
interventions designed to
identify, characterize, and
manage the risks relating to the
use of a medicine.
• An overview of the safety profile
of the medicine, a
pharmacovigilance plan and a
risk-minimization plan.
“Governments should actively and regularly promote pharmacovigilance”

6. Major activities associated with Pharmacovigillance
Pharmacovigilance and Risk Management

7. Post Authorization Studies are necessary
Pharmacovigilance and Risk Management

8. Risk Minimisation Plans (RMP) and Risk
Evaluation and Mitigation Strategies (REMS)

9. Steps for a RMP
•Detection
•Assessment
•Minimisation
•Communication

10. Risk Detection and Assessment
Pharmacoepidemiol Drug Saf. 2010 Jul;19(7):661-9. doi: 10.1002/pds.1948.
Biosimilars: pharmacovigilance and risk management.

11. Risk Minimisation and Communication
Pharmacoepidemiol Drug Saf. 2010 Jul;19(7):661-9. doi: 10.1002/pds.1948.
Biosimilars: pharmacovigilance and risk management.

12. Biologic Registries
Elena Nikiphorou Nature Reviews Rheumatology (2017) doi:10.1038/nrrheum.2017.81
Published online 01 June 2017

13. Biologic Registries

14. Biologic Registries in Latam/Biobadamerica
REAL/PANLAR….

16. Requisitos para la aprobación de
Medicamentos Biosimilares en
Colombia

17. “Guía de elaboración planes de gestión de riesgo que
considere las distintas categorías de medicamentos
biológicos”.
El plan de gestión de riesgo deberá permitir la
optimización del perfil de efectividad y seguridad
(beneficios/eventos adversos) del tratamiento en la
práctica clínica habitual, considerando la información
derivada de todas las fases de desarrollo del

19. Trends in Pharmacovigillance
•Pharmacovigilance Outsourcing (PVO)
• Secondary Data Sources that Contribute to Widespread ADR Reporting: Sentinel Initiative
• Cloud-Based Reporting to Bring a Robust Global Database of ADRs
• Big Data to Protect and Assimilate Huge Amounts of Information
• Data Analytics to Mine Insights
• Automation for Non-Value-Adding Tasks in the PVO Process
• Artificial Intelligence to Turn PVO into a Predictive Science
• An overview of the safety profile of the medicine, a pharmacovigilance plan and a risk-minimization plan.
The worldwide market for Pharmacovigilance services is projected to be
worth $6.1 billion in revenue by 2020.
Industry Trends Shaping the future of Pharmacovigilance

20. Conclusions
• RMP are necessary optimize the profile and risk/
benefit ratio of different treatments
• Biologic experience show that registries are and
important way to gather information about drugs
• RMP should be obligatory to approve a biosimilar
• We must encourage a Pan American registry for
Biologics and Biosimilar

21. Los Esperamos !!!
24 hours ago
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“Como no sabían que era imposible …lo hicieron”
"They did not know it was impossible so they did it “