{"title":"创新与竞争:生物仿制药会成功吗?当前位置建立FDA批准生物仿制药的途径是复杂且充满危险的。是的，创新和市场竞争正处于危急关头。但疗效和患者安全也是如此。","authors":"Erwin A Blackstone, Joseph P Fuhr","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>Biosimilars are here, but there's no clear pathway yet for their approval. Difficult realities about their effect on drug prices, innovation, and competition need to be faced.</p>","PeriodicalId":89534,"journal":{"name":"Biotechnology healthcare","volume":"9 1","pages":"24-7"},"PeriodicalIF":0.0000,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3351893/pdf/bh0901024.pdf","citationCount":"0","resultStr":"{\"title\":\"Innovation and Competition: Will Biosimilars Succeed?: The creation of an FDA approval pathway for biosimilars is complex and fraught with hazard. Yes, innovation and market competition are at stake. But so are efficacy and patient safety.\",\"authors\":\"Erwin A Blackstone, Joseph P Fuhr\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Biosimilars are here, but there's no clear pathway yet for their approval. Difficult realities about their effect on drug prices, innovation, and competition need to be faced.</p>\",\"PeriodicalId\":89534,\"journal\":{\"name\":\"Biotechnology healthcare\",\"volume\":\"9 1\",\"pages\":\"24-7\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2012-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3351893/pdf/bh0901024.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Biotechnology healthcare\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biotechnology healthcare","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Innovation and Competition: Will Biosimilars Succeed?: The creation of an FDA approval pathway for biosimilars is complex and fraught with hazard. Yes, innovation and market competition are at stake. But so are efficacy and patient safety.
Biosimilars are here, but there's no clear pathway yet for their approval. Difficult realities about their effect on drug prices, innovation, and competition need to be faced.
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