First GCC Stakeholder Meeting on Approval Process, Interchangeability/Substitution and Safety of Biosimilars 2017

20 November 2017, Riyadh, Saudi Arabia

GaBI organized the First GCC Stakeholder Meeting on Approval Process, Interchangeability/Substitution and Safety of Biosimilars on 20 November 2017, Riyadh, Saudi Arabia in collaboration with Saudi Pharmaceutical Society (SPS).

The First GCC Stakeholder Meeting on Approval Process, Interchangeability/Substitution and Safety of Biosimilars is an interactive meeting on the regulation, approval and use of biosimilars with a focus on interchangeability/substitution and safety, for regulators from GCC countries (Bahrain, Kuwait, Oman, Saudi Arabia) together with academics, medical practitioners/specialists, pharmacologists and pharmacists (clinical, hospital) from Saudi Arabia, to share knowledge and exchange information with experts from Italy, Norway, Saudi Arabia and the US. Fifty-four participants, speakers included, attended the meeting.

The Scientific Meeting intends to address the issues of physicochemical characterization, analytical comparability, interchangeability/ substitution and safety of biologicals/biosimilars. Representatives from regulatory authorities, academia and medical specialists from Saudi Arabia and GCC countries, who deal with biological and biosimilars, joined together with expert speakers of this scientific meeting to engage in active discussion concerning regulatory approval process, cell line development, hospital formulary selection, switching, and to identify future educational needs.

The meeting focuses on interchangeability/substitution and structure–function of biological medicines. One case study was discussed in the meeting.

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

You can download the speakers’ presentations of this scientific meeting:

The false myths of biosimilars

Challenges related to physicochemical characterization and analytical comparability of biologicals/biosimilars

Biosimilar cell line development

Biologicals and biosimilars – totality of evidence

Biosimilars regulations in Saudi Arabia

Interchangeability for biosimilars: considerations and concerns

Formulary considerations for biosimilars for health systems

Switching from originator product to biosimilars in rheumatology, dermatology and gastroenterology: clinical evidence

Oncologist perspective – the use of biosimilar trastuzumab in breast cancer: clinical experience

Contact us for further information.

Last update: 2018-10-26 Go Back Print

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