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Biosimilar epoetin zeta: extrapolation of indications and real world utilization experience

机译：生物仿制药Epoetin Zeta：适应症和现实世界利用经验的推断

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Introduction: There is an essential need for clinicians to understand the development and approval process of biosimilars. Extrapolation of efficacy and safety data from one indication to another may be considered by a comprehensive comparability program including safety, efficacy and immunogenicity, which detect potentially clinically relevant differences.Areas covered: This article specifically discusses the approval of epoetin zeta (Retacrit, Hospira, a Pfizer company) and the EMA reasoning for extrapolation of indications. Additionally, the results of the ongoing utilization surveillance program that was approved in 2007 and has analyzed over 120 million patient days of epoetin zeta treatment are presented.Expert opinion: At the time of approval, uncertainty of safety and efficacy is much less for biosimilars than for new innovative products. Approval of indications based on extrapolation of data is based on sound and objective scientific criteria and a logical consequence of the biosimilar concept that has been successfully implemented in the European Union.Biosimilar epoetin has been used extensively in patients in Europe for nine years. Following a review of the known risks and ADR information received in almost 120 million patient-days' worth of experience, the risks associated with treatment with epoetin zeta remain similar to those of the reference product.
机译：简介：临床医生非常需要了解生物仿制药的开发和批准过程。包括安全性，功效和免疫原性在内的综合可比性计划，可以考虑将功效和安全性数据从一种适应症外推至另一种适应症，该程序可检测潜在的临床相关差异。辉瑞公司）和EMA推断推断的推理。此外，还提供了正在进行的利用情况监测计划的结果，该计划于2007年获得批准，并分析了超过1.2亿患者的依泊汀Zeta治疗日。专家意见：在批准之时，生物仿制药的安全性和有效性不确定性比用于新的创新产品。基于数据外推的适应症的批准是基于合理和客观的科学标准，是在欧盟成功实施的生物仿制药概念的逻辑结果。生物仿制药的电子表位素已在欧洲患者中广泛使用了九年。在回顾了将近1.2亿患者-天的经验中已知的风险和ADR信息后，依泊汀zeta治疗相关的风险仍与参考产品相似。

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