First INVIMA Educational Workshop on Assessment of Similar Biotherapeutic Products 2016

14 June 2016, Bogotá, Colombia

GaBI organized the First INVIMA Educational Workshop on Assessment of Similar Biotherapeutic Products on 14 June 2016 in Bogotá, Colombia in collaboration with Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), the National Food and Drug Surveillance Institute of Colombia.

The First INVIMA Educational Workshop on Assessment of Similar Biotherapeutic Products (SBPs) is an interactive workshop for regulators and experts of advisory committee of INVIMA. The technical workshop covers the issues on physicochemical characterization, functional assays, cell expression systems, analytical/comparability study, QC standards, and clinical assessment of biologicals/similar biotherapeutic products. This workshop provides a forum for regulators from Colombia to discuss and exchange information with experts from Austria, Finland, The Netherlands, the UK and the US. Thirty-six participants, speakers included, attended the workshop.

The educational workshop intends to raise awareness of the potential differences in quality as well as therapeutic and immunological (immunogenicity) effects of biologicals. Representatives from regulatory authorities who deal with biological and SBPs, joined together with expert speakers of this educational workshop to engage in active discussion concerning the areas of consensus, uncertainty or disagreement concerning the regulation and approval of SBPs, the regulatory assessment of already approved rDNA-derived biotherapeutics, and to identify future educational needs.

The workshop focuses on structure–function of biological medicines. Two case studies were discussed in the workshop.

A meeting report of this workshop has been published in GaBI Journal.

You can download the speakers’ presentations of this educational workshop:

Introduction to a global view of biologicals, biosimilars and non-originator (non-comparable) biologicals and selection of reference products

Principles and challenges related to manufacturing process development and demonstration of analytical comparability for biosimilars – the infliximab case as an example

Clinical and non-clinical assessment of biologicals/biosimilars

Safety assessment and risk management of Biosimilars

Regulatory assessment of already approved rDNA-derived biotherapeutics

Source URL: https://gabi-journal.net/about-gabi/educational-workshops/first-invima-educational-workshop-on-assessment-of-similar-biotherapeutic-products-2016