20 January 2015, Mexico City, Mexico
In 2015, GaBI organized the First Latin American Educational Workshop on Similar Biotherapeutic Products (SBPs) with a focus on regulatory approval, pharmacovigilance and risk management on 20 January 2015 in Mexico City, Mexico, with the support of Cofepris (Federal Commission for the Protection against Sanitary Risk).
The First Latin American Educational Workshop on Similar Biotherapeutic Products is an interactive workshop for regulators, academics and medical practitioners/specialists (oncology/haematology key opinion leaders) from Mexico to discuss and exchange information with experts from Germany, The Netherlands, Thailand, UK and USA. Fifty-five 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, academia and medical specialists, who deal with biological and SBPs, joined together with expert speakers of this educational workshop to engage in active discussion amongst various stakeholders concerning the areas of consensus, uncertainty or disagreement in regulation, pharmacovigilance and risk management for SBPs, and the possible benefits of having distinguishable names for biological products.
The workshop focuses on structure–function of biological medicines, clinical studies and pharmacovigilance (tracking, tracing and the role of nomenclature). Two case studies were discussed in the workshop.
A meeting report of this workshop has been published in GaBI Journal.
Click here to view the event photos.
You can download the speakers’ presentations of this educational workshop:
Welcoming remarks by Mikel Arriola Peñalosa, JP, MPP Federal Commissioner, COFEPRIS, Department of Health, Mexico
Introduction to a global view of biologicals, biosimilars and non-originator (non-comparable) biologicals
Reference products and International Standards/ Reference Reagents: appropriate and inappropriate uses in biosimilar product development
The role of analytical and structure–function studies in the assessment of Biosimilarity
Immunogenicity testing for biotherapeutic products
Biosimilars – totality of evidence for regulatory approval
Safety assessment and risk management of biosimilars: a regulatory perspective
Unwanted immunogenicity of EPO products and related clinical problems (PRCA); the experience in Thailand
The challenges of nomenclature – INN, biosimilars and biological qualifiers
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