23 June 2019, Penang, Malaysia

GaBI organized the 2nd ASEAN Educational Workshop on REGULATORY CONSIDERATIONS FOR BIOSIMILARS on 23 June 2019 in Penang, Malaysia in collaboration with the ACCSQ-PPWG (ASEAN Consultative Committee for Standards and Quality-Pharmaceutical Product Working Group).

The 2nd ASEAN Educational Workshop on REGULATORY CONSIDERATIONS FOR BIOSIMILARS is an interactive workshop on quality assessment and regulatory approval of biosimilars for regulators who are key representatives from ACCSQ–PPWG of ASEAN Member States: Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Phil­ippines, Singapore, Thailand, Vietnam, together with academics, medical practitioners/specialists, pharmacists and procurement specialist, to share knowledge and exchange information with experts from Asia, Canada, Europe and the US. Sixty-one participants, speakers included, attended the workshop.

This educational workshop intends to increase the understanding of the concept of stepwise approach and specific quality evaluation elements on comparability and safety aspects of biologicals/biosimilars including immunogenicity effects of biologicals.  Representatives from regulatory authorities, academia, healthcare professionals from ASEAN Member States who deal with biologicals and biosimilars joined together with expert speakers of this educational workshop to engage in active discussion concerning the importance of quality by design, the significance of regulatory practices to improve pharmacovigilance or post-approval traceability of biotherapeutics to ensure patient safety, and to identify future educational needs.

The workshop focuses on standards and stepwise approach of quality assess­ment of biologicals/biosimilars, structure–function relationship of bio­logical medicines, analytical comparability, non-clinical and clinical studies of biosimilars, extrapolation and interchangeability, switching, as well as post-marketing pharmacovigilance practices of biotherapeutics.

Case study on an oncology monoclonal antibody with three scenarios on structure–function importance of biological medicines was discussed in the workshop.

A meeting report of this workshop will be published in GaBI Journal.

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

Biological/biosimilar regulatory development in the global and ASEAN community: experience from Thailand

Biosimilar regulatory development in the EU – a stepwise approach

Biologicals and biosimilars – the importance of structure and function

Analytical studies used to support biosimilarity in biological drug submission – a regulator’s perspective

Quality by Design (QbD) in process development of therapeutic product

Canada’s approach to non-clinical and clinical assessment of biosimilars

Current regulatory strategies: extrapolation and interchangeability

Interchangeability: US Perspective

An update on biosimilars and switching experience – the clinical perspective

Pharmacovigilance of biotherapeutics

Contact us for further information.

Last update: 2020-05-11 Go Back Print

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