Why are biosimilars much more complex than generics?

Eduardo?Pagani

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Why are biosimilars much more complex than generics?

机译：为什么生物仿制药比非仿制药复杂得多？

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The regulatory demands for registering a generic medicine are physicalchemical tests and one comparative oral bioavailability clinical trial (bioequivalence).(1) This takes about 2 years, costs between USD$1 million and 2 million and enables claims for all indications accepted for the original drug. Demands for a biosimilar include many expensive and time-consuming comparative tests, and efficacy clinical trials for each indication. This takes from 5 to 9 years and costs over USD$100 million.

机译：注册非专利药的监管要求是物理化学测试和一项比较口服生物利用度临床试验（生物等效性）。（1）大约需要2年时间，花费在100万美元至200万美元之间，并能要求对原药接受的所有适应症进行索赔。对生物仿制药的需求包括许多昂贵且费时的对比测试，以及每种适应症的功效临床试验。这需要5到9年的时间，成本超过1亿美元。

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《Einstein (So Paulo)》 |2019年第1期|共2页
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Eduardo?Pagani;
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中图分类预防医学、卫生学;
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机译：副本复合药物：通用，杂种或生物仿制性？
2. Biosimilars: Still Seeking a Door to the MarketBiosimilar medicines are now an established part of the EU regulatory scene, but they have yet to make an impact on the market, and elsewhere progress towards a regulatory framework is slow. Ian Schofield reports from the European Generic medicines Association's latest biosimilars conference. [J] . neena brizmohun The regulatory affairs journal: Pharma . 2008,第6期

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3. Pricing of oral generic cancer medicines in 25 European countries; findings and implications Generics and Biosimilars Initiative Journal (GaBI Journal) [J] . Brian Godman, Steven Simoens GaBi journal. . 2019,第2期

机译：25个欧洲国家/地区的口服仿制药药物的定价;研究结果和启示仿制药和生物仿制药倡议期刊（GaBI Journal）
4. HOS Biosimilarity and Comparability - Objective, Quantifiable HOS Comparisons: A Biosimilar Case Study Utilizing Circular Dichroism [C] . Darek Sliwa Protein Engineering Summit. . 2018

机译：HOS BioSimilliantity和可比性 - 目标，可量化的HOS比较：利用圆形二分的生物仿例研究
5. Biosimilar Uptake in the United States: Examining State-Level Longitudinal Trends in Biosimilar Filgrastim Use and Their Association with Biosimilar Substitution Policies [D] . Grewal, Simrun Kaur. 2020

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6. Why are biosimilars much more complex than generics? [O] . Eduardo Pagani 2019

机译：为什么生物仿制药比非仿制药复杂得多？
7. Generic pregabalin : current situation and implications for health authorities, generics and biosimilars manufacturers in the future [O] . Godman, Brian, Wilcock, Michael, Martin, Andrew, 2015

机译：普瑞巴林（Gene pregabalin）：目前的状况及其对卫生当局，仿制药和生物仿制药制造商的影响

Why are biosimilars much more complex than generics?

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