{"title":"生物制品的后续合成应如何监管?自动替代意味着什么?","authors":"J. Heisterberg","doi":"10.33892/aph.2021.91.108-109","DOIUrl":null,"url":null,"abstract":"Follow-on products referencing biological medicines have from 2005 until recently been licensed as biosimilars in the European Union (EU), because they have themselves been biological medicines. However, synthetically produced follow-on products referencing biological medicines are now emerging. This presentation will address the EU regulatory and scientific challenges associated with these products – primarily with respect to licensing, but also in relation to allowing automatic substitution at the pharmacy level.","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"39 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"How Should Synthetic Follow-Ons of Biological Products Be Regulated? What Are the Implications for Automatic Substitution?\",\"authors\":\"J. Heisterberg\",\"doi\":\"10.33892/aph.2021.91.108-109\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Follow-on products referencing biological medicines have from 2005 until recently been licensed as biosimilars in the European Union (EU), because they have themselves been biological medicines. However, synthetically produced follow-on products referencing biological medicines are now emerging. This presentation will address the EU regulatory and scientific challenges associated with these products – primarily with respect to licensing, but also in relation to allowing automatic substitution at the pharmacy level.\",\"PeriodicalId\":6941,\"journal\":{\"name\":\"Acta pharmaceutica Hungarica\",\"volume\":\"39 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2021-11-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Acta pharmaceutica Hungarica\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.33892/aph.2021.91.108-109\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Acta pharmaceutica Hungarica","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.33892/aph.2021.91.108-109","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
How Should Synthetic Follow-Ons of Biological Products Be Regulated? What Are the Implications for Automatic Substitution?
Follow-on products referencing biological medicines have from 2005 until recently been licensed as biosimilars in the European Union (EU), because they have themselves been biological medicines. However, synthetically produced follow-on products referencing biological medicines are now emerging. This presentation will address the EU regulatory and scientific challenges associated with these products – primarily with respect to licensing, but also in relation to allowing automatic substitution at the pharmacy level.
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