Biological agents and biosimilars: Essential information for the internist
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- 作者：Luca Pasina ; luca.psaina@marionegri.it" class="auth_mail" title="E-mail the corresponding author ; Gianluigi Casadei ; Alessandro Nobili
- 关键词：Biological agents ; Biosimilars ; Drug information ; Regulatory
- 刊名：European Journal of Internal Medicine
- 出版年：2016
- 出版时间：September 2016
- 年：2016
- 卷：33
- 期：Complete
- 页码：28-35
- 全文大小：643 K
文摘
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Biologics are a wide range of substances synthesized by cells or living organisms.
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A biosimilar is a copy of an authorized original biological medicinal product.
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Safety and efficacy of biosimilars are comparable to the originator's.
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The post-marketing safety evaluation is stringent as for any new biological product.