First MENA Educational Workshop on Similar Biotherapeutic Products/Biosimilars 2015

1 September 2015, Dubai, UAE

GaBI organized the First MENA Educational Workshop on Similar Biotherapeutic Products/Biosimilars with a focus on regulation and approval of similar biotherapeutic products/biosimilars on 1 September 2015 in Dubai, United Arab Emirates (UAE), with the support of the UAE Ministry of Health.

The First MENA (Middle East and North Africa) Educational Workshop on Similar Biotherapeutic Products (SBPs)/Biosimilars is an interactive workshop for regulators, academics and medical practitioners/specialists (oncology/nephrology key opinion leaders) from Bahrain, Egypt, Jordan, Kuwait, Lebanon, Oman, Saudi Arabia and United Arab Emirates to discuss and exchange information with experts from Saudi Arabia, Switzerland, Thailand, UAE, the UK and the US. Thirty-seven 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 concerning the regulation and approval of SBPs, and to identify the educational needs of various stakeholders.

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

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 H E Dr Amin Hussein Al Amiri, Assistant Undersecretary of Public Health Policy and Licensing, MOH, UAE

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

WHO standards for evaluation of biotherapeutics including biosimilars

Biologicals and biosimilars – the complexity of structure and function

Immunogenicity testing for biotherapeutic products

Current regulatory approval standard and practice on biosimilars – UAE

Biosimilars regulations in Saudi Arabia

Clinical experience with EPO products approved via the generics pathway: the experience in Thailand

Contact us for further information.

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Generics and Biosimilars Initiative (GaBI)
Tel: +32 474989572 | Fax: +32 14 583 048