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首页> 美国卫生研究院文献>Pharmaceutics >Concepts and Challenges of Biosimilars in Breast Cancer: The Emergence of Trastuzumab Biosimilars
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Concepts and Challenges of Biosimilars in Breast Cancer: The Emergence of Trastuzumab Biosimilars

机译：乳腺癌生物仿制药的概念和挑战：曲妥珠单抗生物仿制药的出现

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With the development of anti-human epidermal growth factor receptor 2 (HER2) monoclonal antibodies, trastuzumab-based therapy has become the standard of care among patients with early or advanced HER2-positive breast cancer. However, real-world data have shown that up to a half of patients do not receive trastuzumab or any other HER2-targeted agent, mainly due to high treatments costs. The prospect of a more enlarged access to trastuzumab treatment lies in the use of biosimilars, as the European and the US patent of the reference products has or will soon expire. Biosimilars are biologics highly similar in terms of quality characteristics, biological activity, safety and efficacy to already approved biologics. The biosimilarity of any European Union (EU)-approved biosimilar is guaranteed based on the comprehensive comparability exercise which includes comparative analytical, non-clinical and clinical studies. In the matter of biosimilars’ interchangeability and substitution, the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have adopted different positions, triggering various discussions on the potential immunogenicity and efficacy in individual patients. As more biosimilars are gaining approval, the present review aims to offer concise information for oncologists and pharmacists about the production, approval, interchangeability, and substitution policies of biosimilars used in breast cancer therapy, with a special focus on trastuzumab.
机译：随着抗人表皮生长因子受体2（HER2）单克隆抗体的发展，基于曲妥珠单抗的疗法已成为早期或晚期HER2阳性乳腺癌患者的治疗标准。但是，现实世界的数据表明，多达一半的患者未接受曲妥珠单抗或任何其他HER2靶向药物，主要是由于治疗费用高。由于参考产品的欧洲和美国专利已经或即将到期，因此使用曲妥珠单抗治疗的机会更大。生物仿制药在质量特征，生物活性，安全性和功效方面与已获批准的生物仿制药高度相似。基于全面的可比性练习，包括比较分析，非临床和临床研究，可以保证任何欧盟（EU）批准的生物仿制药的生物相似性。关于生物仿制药的互换性和替代性问题，欧洲药品管理局（EMA）和美国食品药品监督管理局（FDA）采取了不同立场，引发了有关个别患者潜在免疫原性和功效的各种讨论。随着越来越多的生物仿制药获得批准，本综述旨在为肿瘤学家和药剂师提供有关乳腺癌治疗中使用的生物仿制药的生产，批准，可互换性和替代政策的简明信息，其中特别关注曲妥珠单抗。

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