Interchangeability of levothyroxine sodium tablets

Abstract

The article reviews scientific literature and regulatory documents on safe and efficacious use of levothyroxine medicines. Levothyroxine has less than a twofold difference between the minimal toxic concentration and minimal effective concentration. The article discusses the issue of switching between levothyroxine medicines that can be therapeutically nonequivalent while having proven bioequivalence. The article reviews results of levothyroxine medicines interchangeability studies in different countries. The authors assert the need for improving the coordination of manufacturing and the clinical use of levothyroxine medicines, which will help achieve the equivalence of generic and innovator medicines in the future.

Keywords

• взаимозаменяемость
• биоэквивалентность
• терапевтическая эквивалентность
• воспроизведенные препараты
• препараты левотироксина натрия
• interchangeability
• bioequivalence
• therapeutic equivalence
• generic medicines
• levothyroxine sodium medicines