Drug Discovery Today ( IF 7.4 ) Pub Date : 2018-09-19 , DOI: 10.1016/j.drudis.2018.09.011 Sofia B. Santos , José M. Sousa Lobo , Ana C. Silva
This article provides an updated review of the biosimilar medicines approved for cancer therapy in the European Union (EU). First we discuss the most relevant aspects for the development and approval of biosimilar medicines. We then present the oncological biosimilar drugs currently used, which include epoetins (alpha and zeta), filgrastim, and monoclonal antibodies (rituximab, trastuzumab and bevacizumab). Among the clinical applications of biosimilar medicines, cancer therapy remains the main target area and more approved biosimilars are expected over the next few years, providing cost-effective drugs to more patients. Furthermore, comprehensive pharmacovigilance studies are going on, monitoring the marketed biosimilars, and providing more feasible information to clinicians regarding the safety and efficacy of these medications.
中文翻译:
欧洲用于癌症治疗的生物仿制药综述
本文提供了欧盟(EU)批准用于癌症治疗的生物仿制药的最新综述。首先,我们讨论与生物仿制药有关的最相关方面。然后,我们介绍了目前使用的肿瘤生物仿制药,包括依泊汀(alpha和zeta),非格司亭和单克隆抗体(利妥昔单抗,曲妥珠单抗和贝伐单抗)。在生物仿制药的临床应用中,癌症治疗仍然是主要目标领域,并且在未来几年中有望获得更多批准的生物仿制药,从而为更多患者提供具有成本效益的药物。此外,正在进行全面的药物警戒研究,监测市售的生物仿制药,并向临床医生提供有关这些药物的安全性和有效性的更可行的信息。