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国家替代法律和可互换胰岛素生物类似剂的使用

Youngmin Kwon1, Ameet Sarpatwari2, Stacie B Dusetzina1

  • 1Department of Health Policy, Vanderbilt University Medical Center, Nashville, Tennessee.

JAMA health forum
|April 4, 2025
PubMed
概括

国家替代法对生物类似药的采用有重大影响. 美国各州的较少限制性法律与胰岛素格拉生物类似剂的更高吸收相关,突出了改善获取和降低成本的监管改革的必要性.

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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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