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首页> 外文期刊>Drug Design, Development and Therapy >HX575: established biosimilarity in the treatment of renal anemia and 10 years of clinical experience
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HX575: established biosimilarity in the treatment of renal anemia and 10 years of clinical experience

机译:HX575:在肾性贫血的治疗中已建立的生物相似性和10年的临床经验

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Erythropoiesis-stimulating agents, such as recombinant human erythropoietin, are commonly used for the treatment of anemia in patients with chronic kidney disease (CKD). In 2007, HX575 (Binocrit?) became the first biosimilar epoetin alfa to be approved by the European Medicines Agency (EMA). The decision to approve a biosimilar is based on the totality of evidence obtained in a comprehensive comparability exercise that involves extensive analytical characterization, nonclinical studies and clinical studies. The development process for HX575 included extensive analytical characterization and comparison with the reference epoetin alfa. This was followed by a clinical development program, comprising Phase?I pharmacokinetic/pharmacodynamic studies to show bioequivalence to the reference medicine and a confirmatory Phase?III study to demonstrate therapeutic effectiveness in anemia related to CKD. In addition to the comparability exercises, extensive clinical experience over the last decade also confirms that HX575 provides an effective treatment for CKD-related anemia, with a favorable safety profile. Growing clinical experience with EMA-approved biosimilars, including HX575, should offer additional reassurance to health care professionals and patients that these agents are as effective and well tolerated as others in the therapeutic class.
机译:促红细胞生成素刺激剂,例如重组人促红细胞生成素,通常用于治疗慢性肾脏病(CKD)患者的贫血。在2007年,HX575(Binocrit ?)成为了首个被欧洲药品管理局(EMA)批准的生物仿制药epoetin alfa。批准生物仿制药的决定是基于在全面的可比性练习中获得的全部证据,其中涉及广泛的分析特性,非临床研究和临床研究。 HX575的开发过程包括广泛的分析表征和与参考依泊汀α的比较。随后是一项临床开发计划,包括I期药代动力学/药效学研究,以显示与参考药物的生物等效性;以及III期证实性研究,以证明对与CKD相关的贫血具有治疗效果。除了可比性练习外,近十年来广泛的临床经验还证实,HX575可为CKD相关性贫血提供有效的治疗方法,并具有良好的安全性。使用EMA批准的生物仿制药(包括HX575)的临床经验不断增长,应该使医疗保健专业人员和患者更加放心,这些药物与治疗类药物一样有效且耐受性强。

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