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从“重磅炸弹药物”到“生物类似药”:为患者、医学专家和医疗保健提供者带来的机遇。

From "blockbusters" to "biosimilars": an opportunity for patients, medical specialists and health care providers.

机构信息

Allergy & Respiratory Diseases Clinic-University of Genoa, IRCCS-AOU San Martino, Pad. Maragliano, Largo Rosanna Benzi 10, 16132 Genova, Italy.

出版信息

Pulm Pharmacol Ther. 2012 Dec;25(6):483-6. doi: 10.1016/j.pupt.2012.09.005. Epub 2012 Sep 23.

Abstract

Advances in basic research and research and development plans of pharmaceutical companies are radically changing the kind of available drugs and therapeutic targets. We are switching from predominantly chemical molecules, aimed at treating large populations of patients (blockbuster drugs), to a new generation of products, mostly biotech, aimed at modifying a specific pathogenetic mechanism. In other word we are moving fast to targeted therapy, which represents the first step toward personalized therapy, where the right drug at the right dose is administered to the right person, at the right time. Like the patent expiration of chemical products has corresponded to the development of generic drugs, the expiration of new biotech products will witness the appearance of biosimilars. The latter are biologic products that are highly similar but not identical to the reference medical products in terms of quality, safety and efficacy. This implies specific research, clinical monitoring, physicians updating of knowledge for a safe and appropriate use of these products. We are the beginning of a devolution in patient's care and physicians' practice.

摘要

基础研究和制药公司研发计划的进展正在从根本上改变可用药物和治疗靶点的种类。我们正在从主要针对治疗大量患者(重磅炸弹药物)的化学分子转向新一代产品,主要是生物技术,旨在修饰特定的发病机制。换句话说,我们正在快速向靶向治疗迈进,这是迈向个体化治疗的第一步,即在正确的时间向正确的人给予正确剂量的正确药物。就像化学产品的专利到期对应着仿制药的发展一样,新的生物技术产品的专利到期将见证生物类似药的出现。后者是指在质量、安全性和疗效方面与参照医疗产品高度相似但并非完全相同的生物制品。这意味着需要进行特定的研究、临床监测以及医生更新知识,以确保这些产品的安全和合理使用。我们正处于患者护理和医生实践的转变的开始。

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