Institut Multidisciplinaire d'Oncologie, Clinique de Genolier, Genolier, Switzerland.
Hematology/Nephrology, Sandoz Biopharmaceuticals, HEXAL AG, Industriestr. 25, 83607, Holzkirchen, Germany.
BioDrugs. 2018 Apr;32(2):129-135. doi: 10.1007/s40259-018-0262-9.
High-quality, safe, and effective biosimilars have the potential to increase access to biological therapies worldwide and to reduce cancer care costs. The European Medicines Agency (EMA) was the first regulatory authority to establish legislative procedures for the approval of biosimilars when they published their guidelines on similar biological medicinal products in 2005. Biosimilar epoetins were first approved in 2007, and a wealth of data has been collected over the last decade. Two biosimilar epoetins (under five commercial names) have been approved by the EMA so far. The availability of epoetin biosimilars generated discussion among the oncology community regarding prescribing these products, their efficacy, and their safety. These agents are approved only if they are shown in extensive analytical and clinical testing to have comparable quality, safety, and efficacy to the reference medicine, and real-world studies provide further data that biosimilar epoetins are an effective and well-tolerated option for the treatment of chemotherapy-induced anemia in patients with cancer. Other countries have adopted similar regulatory pathways to those in Europe and have approved epoetin biosimilars. The now extensive European experience with biosimilar epoetins should reassure regulators from other territories.
高质量、安全且有效的生物类似药有可能增加全球范围内生物治疗药物的可及性，并降低癌症治疗成本。欧洲药品管理局（EMA）是第一个为生物类似药批准建立立法程序的监管机构，其在 2005 年发布了类似生物药品的指导原则。2007 年首次批准了生物类似性促红细胞生成素，在过去十年中收集了大量数据。迄今为止，EMA 已经批准了两种生物类似性促红细胞生成素（五种商品名）。促红细胞生成素生物类似药的出现引发了肿瘤学界关于开处方这些产品、其疗效和安全性的讨论。这些药物只有在经过广泛的分析和临床测试证明与参比药物具有相当的质量、安全性和疗效时才会获得批准，而真实世界的研究提供了进一步的数据，表明生物类似性促红细胞生成素是治疗癌症患者化疗引起的贫血的有效且耐受良好的选择。其他国家也采用了与欧洲类似的监管途径，并批准了促红细胞生成素生物类似药。欧洲现在在生物类似性促红细胞生成素方面拥有广泛的经验，这应该能让来自其他地区的监管机构感到安心。
