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Sunderland Repository records the research produced by the University of Sunderland including practice-based research and theses.

Biosimilar antibodies

Elkordy, Amal and Singh, Kamalinder K. (2023) Biosimilar antibodies. In: Formulation of Monoclonal Antibody Therapies: From Lab to Market. Elsevier, pp. 39-52. ISBN 9780128233658

Item Type: Book Section


Biosimilars are similar biotherapeutic products in general. The first biosimilars were erythropoietins and somatropines (which are not mAbs, monoclonal antibodies). However, Riabni (rituximab-arrx) is the most recent US Food and Drug Administration (FDA) approved biosimilar monoclonal antibody. Due to the complex protein molecular structure of mAbs and the complexity of mAbs production, the development of biosimilar mAbs is complicated. For the biosimilar to be proved similar to the original, or reference, mAb, robust clinical and non-clinical data (to support the use of the product in targeting the disease) are required for the new biosimilar product. Additionally, after marketing a vigorous pharmacovigilance plan needs to be in place. Biosimilars proved in a short time of application to benefit patients and the healthcare system. However, their use is a responsibility of a broad healthcare community.

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Depositing User: Amal Elkordy


Item ID: 16198
ISBN: 9780128233658
Official URL:

Users with ORCIDS

ORCID for Amal Elkordy: ORCID iD

Catalogue record

Date Deposited: 01 Jun 2023 16:38
Last Modified: 01 Jun 2023 16:38


Author: Amal Elkordy ORCID iD
Author: Kamalinder K. Singh

University Divisions

Faculty of Health Sciences and Wellbeing > School of Pharmacy and Pharmaceutical Sciences


Sciences > Pharmacy and Pharmacology

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