Analytical Similarity Assessment of Bevacizumab Biosimilar Candidate MB02 Using Multiple State-of-the-art Assays

Joint Meet on 31^st Annual European PHARMA CONGRESS & 14^th European BIOSIMILARS CONGRESS

April 28, 2021 WEBINAR

Marie-Elise Beydon

Daniel Sacristan, Isabel Ruppen, mAbxience, Madrid, Spain

Posters & Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

MB02 (Alymsys®) is a candidate biosimilar to bevacizumab which was developed against the reference product (RP) Avastin® sourced from both the European Union (EU) and United States (US). MB02 has been extensively characterized comparatively to Avastin® at physicochemical and biological level using sensitive orthogonal state-of-the-art analytical methods. MB02 has been demonstrated similar to the RP with regard to its primary and higher order structure, post- and co-translational profiles such as glycosylation, charge and size variants. Specific focus has been put on the characterization of Fab-related activities, such as binding to VEGF A 165, which directly reflect bevacizumab mechanism of action. Fc-related functionality was also investigated, including binding to FcRn, which is indicative of antibodies half-life. The data generated during the analytical similarity assessment demonstrate high analytical similarity of MB02 to its RP.

Biography :

Marie-Elise Beydon is a biochemist from Nice University, France with an MSc in International Drug Development and Registration from Paris XI university. She has over 15 years experience in the pharmaceutical industry with over 10 working with biosimilars. She is currently R&D CMC Team Leader at mAbxience in Spain where she leads the extended characterization activities for their biosimilar portfolio, including demonstration of analytical similarity.