Biosimilar monoclonal antibodies (mAbs) in oncology

Abstract

Biological medicines are derived from living cells and organisms. Monoclonal antibodies (mAbs) are biological agents that are widely used to treat malignancies including non-Hodgkin's lymphomas and chronic lymphocytic leukaemia. They are effective but expensive. The patents for many mAbs are expiring, so biosimilar medicines, which contain a version of the active ingredient of the original drug, are being developed. Biological medicines cannot be assessed in the same way as standard generic medications because they are difficult to copy and can change over time. A pathway regulates how biosimilars are assessed and compared with the original drug to ensure they are highly similar and have no clinically meaningful differences in terms of structure, function, pharmacodynamics and mechanism of action, pharmacokinetic properties, clinical efficacy and safety. Truxima(rituximab), the first biosimilar monoclonal antibody to be approved for use in the UK in an oncology setting, is biosimilar to intravenous (IV) rituximab; rituximab improves the effectiveness of standard chemotherapy for lymphoma. The two drugs are comparable in efficacy and safety and have the same indications, dosing regimen and storage procedures.

Catastrophic antiphospholipid syndrome presented with coronary thrombosis, renal impairment, and suspected diffuse alveolar hemorrhage treated with rituximab biosimilar (CT-P10)

“…In addition, the indications and dose used were the same as those for rituximab. 11,12 A recent multicenter study of systemic sclerosis showed that CT-P10 caused only transient neutropenia and was similar to rituximab in efficacy and other safety profiles. 13 Biosimilars are biological products that contain the active substance of an already authorized original product.…”

Tracking the CAR-T Revolution: Analysis of Clinical Trials of CAR-T and TCR-T Therapies for the Treatment of Cancer (1997–2020)

“…In light of the recent success (and future potential) of CAR-T/TCR-T therapies for the treatment of cancer, we aim to provide a comprehensive overview of the growth of the clinical trials space for these products, and to highlight some of the factors driving this growth. One such factor is the nature of CAR-T/TCR-T immunotherapies, which makes it possible to develop many different products that use analogous therapeutic approach to achieve comparable clinical efficacy [15,16]. Such CAR-T/TCR-T products that are currently in the clinical pipeline cannot be characterized as biosimilar products in the narrow sense of the term, so we propose that CAR-T/TCR-T products that use a parallel therapeutic approach be termed bioparallels.…”

Tracking the CAR-T Revolution: Analysis of Clinical Trials of CAR-T and TCR Therapies for the Treatment of Cancer (1997-2020)

“…clinical trials space for these products, and to highlight some of the factors driving this growth. One such factor is the nature of CAR-T/TCR immunotherapies which makes it possible to develop many different products that use analogous therapeutic approach to achieve comparable clinical efficacy [7,8]. Such CAR-T/TCR products that are currently in the clinical pipeline cannot be characterized as biosimilar products in the narrow sense of the term, so we propose that CAR-T/TCR products that use a parallel therapeutic approach be termed bioparallels.…”