Biosimilars for breast cancer: a review of HER2-targeted antibodies in the United States

Miller, Emily; Schwartzberg, Lee S.

doi:10.1177/1758835919887044

Cited by 27 publications

(19 citation statements)

References 34 publications

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“…In 2019, WHO included the biosimilars of trastuzumab in its essential medicines list, integrating the previous inclusion of the biosimilars of erythropoietin agents and filgrastim [ 112 ]. Currently, there are six approved trastuzumab biosimilars, which have shown equivalent efficacy to trastuzumab [ 113 ]. The wide distribution and utilization of such biosimilars in LMIC should be encouraged and not misperceived as merely cheaper options for poorer countries [ 111 ].…”

Section: Discussionmentioning

confidence: 99%

Implementation of Breast Cancer Continuum of Care in Low- and Middle-Income Countries During the COVID-19 Pandemic

et al. 2020

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Breast cancer is the most common malignancy among women worldwide. The current COVID-19 pandemic represents an unprecedented challenge leading to care disruption, which is more severe in low- and middle-income countries (LMIC) due to existing economic obstacles. This review presents the global perspective and preparedness plans for breast cancer continuum of care amid the COVID-19 outbreak and discusses challenges faced by LMIC in implementing these strategies. Prioritization and triage of breast cancer patients in a multidisciplinary team setting are of paramount importance. Deescalation of systemic and radiation therapy can be utilized safely in selected clinical scenarios. The presence of a framework and resource-adapted recommendations exploiting available evidence-based data with judicious personalized use of current resources is essential for breast cancer care in LMIC during the COVID-19 pandemic.

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Section: Discussionmentioning

confidence: 99%

Implementation of Breast Cancer Continuum of Care in Low- and Middle-Income Countries During the COVID-19 Pandemic

et al. 2020

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“…Given the similar pharmacokinetic and clinical profiles of the IV and SC trastuzumab formulations, a number of additional factors, such as route of administration, patient preference, value of the health technology and cost, should be considered by healthcare providers during their decision making regarding which formulation of trastuzumab to administer. Additionally, given the increasing availability of trastuzumab biosimilars, 11 , 12 healthcare providers should contemplate the possible advantages of these agents, too, when evaluating potential biologic therapeutic options. The current biologic therapy landscape of EBC and MBC is rich, and offers numerous options for patients and healthcare providers, which necessitates a careful consideration of preferences and costs involved, as outlined below.…”

Section: Additional Considerations For Therapeutic Optionsmentioning

confidence: 99%

“…Patent expirations for trastuzumab in the European Union (2014) and USA (2019) have prompted the development of several trastuzumab biosimilars 11 and, to date, five trastuzumab biosimilars have been approved by the FDA and European Medicines Agency: trastuzumab-dkst (Mylan GmbH, Steinhausen, Switzerland), trastuzumab-pkrb (Celltrion Inc., Incheon, Republic of Korea), trastuzumab-dttb (Samsung Bioepis Co., Ltd, Incheon, Republic of Korea), trastuzumab-qyyp (Pfizer Ireland Pharmaceuticals, Cork, Ireland) and trastuzumab-anns (Amgen Inc., Thousand Oaks, CA, USA). 11 , 12 All currently approved trastuzumab biosimilars are formulated for IV use only, although the eventual patent expiration of SC trastuzumab (anticipated in 2030 in the USA) might allow for the development of SC biosimilar formulations in the future.…”

Section: Introductionmentioning

confidence: 99%

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

2021

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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.

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“… 6 , 70 In a recent study, trastuzumab was not shown to be cost-effective in 11 African countries at current prices. 70 Shortened trastuzumab regimens for early BC, as well as availability of multiple biosimilars for all BC, 71 will reduce drug costs. Yet, affordability in sub-Saharan Africa may require global cost-reduction strategies similar to prior collaborations to bring effective antiretroviral medications to low-income countries.…”

Section: Discussionmentioning

confidence: 99%

Receptor-Defined Breast Cancer in Five East African Countries and Its Implications for Treatment: Systematic Review and Meta-Analysis

Popli

Gutterman

Omene

et al. 2021

JCO Global Oncology

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PURPOSE Estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor-2 (HER2) are determinants of treatment and mortality for patients with breast cancer (BC). In East Africa, the estimated 5-year survival (37.7%) is far lower than the US average (90%). This meta-analysis investigates BC receptor subtypes within five East African countries to ascertain cross-country patterns and prioritize treatment needs. METHODS From a PubMed search, January 1, 1998-June 30, 2019, for all English-only BC articles for Ethiopia, Kenya, Rwanda, Tanzania, and Uganda, eligible studies had receptor distributions for female BC samples ≥ 30 patients. Outcomes were proportions of ER+, PR+, and HER2-positive (HER2+), and/or molecular subtypes. Data included study characteristics and mean or median patient age. Using metaprop, Stata 16, we estimated pooled proportions (ES) with 95% CIs and assessed heterogeneity. RESULTS Among 36 BC studies with receptor data, 21 met criteria. Weighted mean age was 47.5 years and median, 48. Overall ES were as follows: 55% for ER-positive (ER+) (95% CI, 47 to 62), 23% for HER2+ (95% CI, 20 to 26), and 27% for triple-negative BC (TNBC) (95% CI, 23 to 32). CONCLUSION We found differences between countries, for example, lower distribution of TNBC in Ethiopia (21%) compared with Uganda (35%). ER+, the dominant BC subtype overall at 55%, emphasizes the need to prioritize endocrine therapy. Overall proportions of HER2+ BC (with or without ER+ or PR+), 23%, approached proportions of TNBC, 27%, yet HER2 testing and treatment were infrequent. Testing and reporting of receptor subtypes would promote delivery of more effective treatment reducing the mortality disparity.

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Biosimilars for breast cancer: a review of HER2-targeted antibodies in the United States

Cited by 27 publications

References 34 publications

Implementation of Breast Cancer Continuum of Care in Low- and Middle-Income Countries During the COVID-19 Pandemic

Implementation of Breast Cancer Continuum of Care in Low- and Middle-Income Countries During the COVID-19 Pandemic

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

Receptor-Defined Breast Cancer in Five East African Countries and Its Implications for Treatment: Systematic Review and Meta-Analysis

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