Intravenous and subcutaneous formulations of trastuzumab, and trastuzumab biosimilars: implications for clinical practice

Abstract

Trastuzumab is a biologic therapy indicated for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer and metastatic gastric cancer. Trastuzumab was originally approved as an intravenous (IV) formulation but has since been developed for subcutaneous (SC) administration for patients with HER2-positive breast cancer. Both formulations demonstrate generally comparable pharmacological and clinical profiles. Therefore, when deciding between treatment options, factors such as the route of administration, patient preference, value and cost must be considered. Studies comparing IV with SC trastuzumab indicate that each formulation offers unique advantages to patients depending on their individual needs. Concurrent with the development of SC trastuzumab, IV trastuzumab biosimilars comprise another treatment option that, in view of their reduced cost, might improve patient access and increase cost-effectiveness for healthcare providers and payers. In this review, we seek to raise awareness of the current options available for trastuzumab so that healthcare providers can optimally treat patients according to their individual situations and preferences.

Effectiveness and Safety of Zercepac and Reference Trastuzumab in the Neoadjuvant Setting for Early-Stage Breast Cancer: A Retrospective Cohort Study

“…Previous studies have confirmed the efficacy of reference trastuzumab in patients with HER2-positive metastatic breast cancer combined with chemotherapy [ 15 , 26 ] and neoadjuvant therapy [ 11 , 27 ]. Patent expirations for trastuzumab in the European Union (2014) and USA (2019) have led the development of several bioequivalent drugs with low development costs [ 28 ]. In the neoadjuvant setting, both biosimilar SB3 and CT-P6 were equivalent to reference trastuzumab with respect to pCR (SB3: 51.7% and 42.0%; CT-P6: 46·8% and 52.4%) in phase 3, randomized trials [ 29 , 30 ].…”

Clinical and treatment characteristics of patients treated with the first therapeutic oncology biosimilars bevacizumab-awwb and trastuzumab-anns in the US

“…For the bevacizumab cohort, ‘pre-exposed’ patients were defined as those with documented prior use of any marketed bevacizumab product, including the bevacizumab RP and the bevacizumab biosimilar Zirabev (bevacizumab-bvzr), at any time prior to the initiation of bevacizumab-awwb. For the trastuzumab cohort, ‘pre-exposed’ patients were defined as those with recorded previous use of any marketed trastuzumab products, including the trastuzumab RP (Herceptin), subcutaneous formulation of trastuzumab (Herceptin HYLECTA), 32 , 33 and other trastuzumab biosimilars Ogivri (trastuzumab-dkst), Trazimera (trastuzumab-qyyp), Herzuma (trastuzumab-pkrb), and Ontuzant (trastuzumab-dttb), at any time prior to the initiation of trastuzumab-anns. Bevacizumab or trastuzumab-naïve patients were defined as those with no recorded previous use of the above-mentioned bevacizumab or trastuzumab products (including RPs and biosimilars) prior to the initiation of bevacizumab-awwb or trastuzumab-anns.…”

Editorial: Translational Research and Drug Repurposing for Non-Communicable Diseases (NCDs)

“…Trastuzumab (TZM) is a monoclonal antibody employed in the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer and metastatic gastric cancer ( Waller et al, 2021 ). Cardiac dysfunction is a cause for concern in the use of this biologic.…”