Uifălean Alina, Ilieş Maria, Nicoară Raul, Rus Lucia Maria, Hegheş Simona Codruţa, Iuga Cristina-Adela
Department of Pharmaceutical Analysis, Faculty of Pharmacy, "Iuliu Hațieganu" University of Medicine and Pharmacy, Louis Pasteur Street 6, 400349 Cluj-Napoca, Romania.
Department of Proteomics and Metabolomics, MedFuture Research Center for Advanced Medicine, "Iuliu Hațieganu" University of Medicine and Pharmacy, Louis Pasteur Street 4-6, Gh. Marinescu Street 23, 400349 Cluj-Napoca, Romania.
Pharmaceutics. 2018 Sep 25;10(4):168. doi: 10.3390/pharmaceutics10040168.
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.
随着抗人表皮生长因子受体2（HER2）单克隆抗体的发展，基于曲妥珠单抗的治疗已成为早期或晚期HER2阳性乳腺癌患者的标准治疗方案。然而，真实世界的数据显示，高达一半的患者未接受曲妥珠单抗或任何其他HER2靶向药物治疗，主要原因是治疗费用高昂。随着参比产品的欧洲和美国专利已经或即将到期，扩大曲妥珠单抗治疗可及性的前景在于生物类似药的使用。生物类似药是在质量特性、生物活性、安全性和有效性方面与已批准生物制品高度相似的生物制品。任何欧盟（EU）批准的生物类似药的生物相似性都是基于包括比较分析、非临床和临床研究在内的全面可比性研究来保证的。在生物类似药的可互换性和替换性问题上，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，引发了关于个体患者潜在免疫原性和疗效的各种讨论。随着越来越多的生物类似药获得批准，本综述旨在为肿瘤学家和药剂师提供关于用于乳腺癌治疗的生物类似药的生产、批准、可互换性和替换政策的简明信息，特别关注曲妥珠单抗。
