The devolution of biosimilars regulations

IF 33.1 1区生物学 Q1 BIOTECHNOLOGY & APPLIED MICROBIOLOGY

Nature biotechnology Pub Date : 2024-12-16 DOI:10.1038/s41587-024-02497-5

Erik Doevendans, Peter van Meer, Huub Schellekens

引用次数: 0

Abstract

After two decades of experience with biosimilars, physicochemical and in vitro biological comparison with their reference products appear sufficient to guarantee clinical safety and efficacy. Hence, the regulation of biosimilars has become redundant, and biopharmaceuticals should now be regulated through the generic pathway available for small molecules.

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经过二十年的生物仿制药经验，与参照产品进行理化和体外生物学比较似乎足以保证临床安全性和有效性。因此，对生物仿制药的监管已变得多余，现在应通过小分子药物的仿制途径对生物制药进行监管。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Nature biotechnology 工程技术-生物工程与应用微生物

CiteScore

63.00

自引率

1.70%

发文量

382

审稿时长

3 months

期刊介绍： Nature Biotechnology is a monthly journal that focuses on the science and business of biotechnology. It covers a wide range of topics including technology/methodology advancements in the biological, biomedical, agricultural, and environmental sciences. The journal also explores the commercial, political, ethical, legal, and societal aspects of this research. The journal serves researchers by providing peer-reviewed research papers in the field of biotechnology. It also serves the business community by delivering news about research developments. This approach ensures that both the scientific and business communities are well-informed and able to stay up-to-date on the latest advancements and opportunities in the field. Some key areas of interest in which the journal actively seeks research papers include molecular engineering of nucleic acids and proteins, molecular therapy, large-scale biology, computational biology, regenerative medicine, imaging technology, analytical biotechnology, applied immunology, food and agricultural biotechnology, and environmental biotechnology. In summary, Nature Biotechnology is a comprehensive journal that covers both the scientific and business aspects of biotechnology. It strives to provide researchers with valuable research papers and news while also delivering important scientific advancements to the business community.