23 July 2017, Bangkok, Thailand

GaBI organized the First ASEAN Educational Workshop on Regulation and Approval of Biosimilars/Similar Biotherapeutic Products on 23 July 2017 in Bangkok, Thailand in collaboration with the ASEAN (Association of Southeast Asian Nations) ACCSQ-PPWG.

The First ASEAN Educational Workshop on Regulation and Approval of Biosimilars/Similar Biotherapeutic Products is an interactive workshop on the regulation and approval of biosimilars for regulators who are key representatives from ACCSQ–PPWG of ASEAN Member States: Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam; together with academics, medical practitioners/specialists, pharmacists and procurement specialist from Singapore and Thailand to discuss and exchange information with experts from Asia, Europe and the US. Forty-three participants, speakers included, attended the workshop.

The educational workshop intends to address the issue of potential differences in quality as well as therapeutic and immunological (immunogenicity) effects of biologicals. Representatives from regulatory authorities, academia and medical specialists from ASEAN Member States, who deal with biological and biosimilars, joined together with expert speakers of this educational workshop to engage in active discussion concerning principles and challenges related to manufacturing process development for biosimilars, clinician’s experience of biocopy EPO, regulatory experience of re-evaluating erythropoietin, and to identify future educational needs.

The workshop focuses on structure–function of biological medicines. One case study was 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

Biologicals and biosimilars – totality of evidence

Immunogenicity testing for biotherapeutic products

Clinical and non-clinical assessment of biologicals/biosimilars

Regulatory assessment of already approved rDNA-derived biotherapeutics

Clinician’s experience of biocopy EPO in Thailand

Experience of re-evaluating erythropoietin in Thailand

Safety assessment and risk management of biosimilars, knowledge gaps of physicians and patients

Contact us for further information.