Biosimilar antibodies

Elkordy, Amal Ali and Singh, Kamalinder orcid iconORCID: 0000-0001-7325-0711 (2023) Biosimilar antibodies. In: Formulation of Monoclonal Antibody Therapies. Elsevier, pp. 39-52. ISBN 978-0-12-823365-8

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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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