Bakhtiar, M. Taher and Muhamad, Nur Syahirah Izzati and Jalaludin, Anis Izzati and Abdul Ghafur, Nur Aina and Lela Murad, Nuryn Lela Adenin and Ediamin, Nurain Batrisyia (2026) Biosimilar monoclonal antibodies. In: Springer Handbook of Medical Biotechnology. Springer, pp. 251-264. ISBN 978-3-032-01635-5
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Abstract
Monoclonal antibodies (MAbs) are the magic bullet mol- ecules that have been crowned as one of the personalized medicines due to their high degree of specificity charac- teristics on the diseases. MAbs products have become top-selling biopharmaceutical products for many consec- utive years including in the year 2023 led by Keytruda® (pembrolizumab) with a revenue of USD 12.00 billion. Cancer, rheumatoid arthritis, psoriasis, and Crohn’s dis- eases are the main target of MAbs through their effective and efficient action. The remarkable effect of MAbs on cancer has led to the fastest-growing biological extent of production at an affordable price. This can be achieved by the introduction of low-cost products, namely, biosimilars. A biosimilar product possesses high similarity toward the originator which underwent less expensive cost and shorter clinical trials. The biological activity of biosimilar biologics is comparable toward the original product. Biosimilars are marketed following the exclusive patent of the originator. To date, 37 biosimilar MAbs have been approved by the United States Food and Drug Adminis- tration with 10 of them using adalimumab under the licensing of Humira®. This chapter covers an update of the biosimilar MAbs that have been approved together with their description focusing on of infliximab, adalimumab, bevacizumab, trastuzumab, and rituximab.
| Item Type: | Book Chapter |
|---|---|
| Subjects: | R Medicine > RS Pharmacy and materia medica > RS192 Materia Medica-Pharmaceutical Technology |
| Kulliyyahs/Centres/Divisions/Institutes (Can select more than one option. Press CONTROL button): | Kulliyyah of Pharmacy > Department of Pharmaceutical Technology |
| Depositing User: | Dr Muhammad Taher |
| Date Deposited: | 18 May 2026 15:39 |
| Last Modified: | 18 May 2026 15:39 |
| Queue Number: | 2026-05-Q3349 |
| URI: | http://irep.iium.edu.my/id/eprint/128991 |
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