Republican Healthcare Bill Proposes Biosimilar Pathway

David Belian

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Republican Healthcare Bill Proposes Biosimilar Pathway

机译：共和党医疗保健法案提出生物仿制药道路

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A bill released by House Republicans has a 12-year exclusivity period, which matches language proposed in the Democrats' House healthcare overhaul bill and the Senate Health, Education, Labor and Pensions (HELP) Committee version.rnThe Republican measure was written as a substitute for the Affordable Health Care for America Act, H.R. 3962 - which is tentatively scheduled for a Saturday vote in the full House, Andrew Foxwell, spokesman for Rep. Erik Paulsen (R-Minn.), told WDL. Senate lawmakers are waiting on a Congressional Budget Office (CBO) cost estimate on a unified Senate healthcare bill.

机译：众议院共和党人发布的法案有12年的独占期，与民主党众议院医疗改革法案和参议院卫生，教育，劳动和退休金（HELP）委员会版本中提议的措辞相符。众议员埃里克·保尔森（R-Minn。）的发言人安德鲁·福克斯韦尔（Andrew Foxwell）对《美国平价医疗法案》（HR 3962）进行了初步安排，该法案暂定于星期六在参议院进行表决。参议院议员正在等待国会预算办公室（CBO）对统一参议院医疗法案的成本估算。

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《Washington Drug Letter》 |2009年第44期|3|共1页
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David Belian;
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6. Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy [O] . Kalpna Desai, Priya Misra, Sanyukta Kher, 2018

机译：临床证实证明生物仿制药吡格非司亭具有相似性：一项针对拟进行的生物仿制药吡格非司亭与美国许可和欧盟批准的参考药物在接受骨髓抑制化学疗法的乳腺癌患者中进行的三项随机等效研究
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机译：临床确认，证明生物仿制性PEGFILGRASTIM的相似性：用于拟议的生物仿生蛋白的3路随机性等效研究与接受骨髓抑制化疗的乳腺癌患者的美国许可和欧盟批准的参考产品

Republican Healthcare Bill Proposes Biosimilar Pathway

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