Trastuzumab Biosimilars Setting the Pace for the Provision of a Cost Effective Oncological Care: Regulatory and Clinical Issues - Abstract
Anti-HER2 directed treatment has become the standard of care among patients with early and advanced HER2-positive breast cancer. Owing to the associated treatment costs, barriers such as insurance coverage and availability prevent its use in neoadjuvant, adjuvant or metastatic settings in many developing countries. In 2017, the patent for intravenous trastuzumab (Herceptin) expired across Europe, promoting the development of trials with trastuzumab biosimilars. Biosimilars are products that are developed to be highly similar in terms of safety, purity and potency to existing approved biologics. They may represent a potential opportunity to lower the cost of treatment and increase patient accessibility to important drugs. Four trastuzumab biosimilars have already been approved for routine use in Europe with others likely to follow. Here, we provide a detailed review of trastuzumab biosimilars; and discuss important regulatory and clinical considerations that must be addressed and appreciated as these agents enter routine cancer care.