Questioning how much similar are biosimilar deemed to be similar enough to the originator? Spotting the difference puzzle is a fun, so why not biosimilar!
Education and experience:
• Bachelor degree in Biochemistry (BSc.), College of science at King Saud University, Riyadh, Saudi Arabia
• Master degree in Biomedical lab science (MSc), College of health science at Quinnipiac university, CT, USA
• Quality assessor for biological medicines including vaccines, blood products, recombinant proteins and biosimilar in the drug sector at Saudi FDA
• Member and government liaison in the committee for complex biologics monographs -3 at U.S Pharmacopeia (cycle 2015-2020)
Title PhD project:
The quality and regularity landscape of biosimilar medicines.
PhD project description:
The quality assessment has become important tool to detect tiny structural or functional differences when comparing a biosimilar to its originator counterpart. However, deciding on the acceptable margin to define the similarity degree at quality level remains challenging due to product heterogeneity and nonexistence of a harmonized scale for measuring quality attributes.
The project focuses on investigating methodologies, development and challenges in similarity assessment of biosimilar. The main focus is on the quality assessment of biosimilars as different methods are used by regulatory bodies to assess biosimilarity as well as assessing the clinical relevance of quality attributes included in similarity assessments.
Teammembers and other people involved:
Dr. Thijs Giezen, Dr. Helga Gardarsdottir, Prof. Bert Leufkens.