With the development of anti-human epidermal growth factor receptor 2 (HER2)\nmonoclonal antibodies, trastuzumab-based therapy has become the standard of care among patients\nwith early or advanced HER2-positive breast cancer. However, real-world data have shown that\nup to a half of patients do not receive trastuzumab or any other HER2-targeted agent, mainly due\nto high treatments costs. The prospect of a more enlarged access to trastuzumab treatment lies\nin the use of biosimilars, as the European and the US patent of the reference products has or will\nsoon expire. Biosimilars are biologics highly similar in terms of quality characteristics, biological\nactivity, safety and efficacy to already approved biologics. The biosimilarity of any European\nUnion (EU)-approved biosimilar is guaranteed based on the comprehensive comparability exercise\nwhich includes comparative analytical, non-clinical and clinical studies. In the matter of biosimilarsâ??\ninterchangeability and substitution, the European Medicines Agency (EMA) and US Food and\nDrug Administration (FDA) have adopted different positions, triggering various discussions on\nthe potential immunogenicity and efficacy in individual patients. As more biosimilars are gaining\napproval, the present review aims to offer concise information for oncologists and pharmacists about\nthe production, approval, interchangeability, and substitution policies of biosimilars used in breast\ncancer therapy, with a special focus on trastuzumab.
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