Abstract

The paper generalizes the experience with one of the main original drugs for the treatment of multiple sclerosis (MS) – glatiramer acetate (GA, Copaxone ® , Teva) in large Russian MS centers. The performed analysis of clinical trials suggests the high efficacy and favorable safety profile of the drug. The fact that patents for a number of effective and widely used original drugs, including those for agents from a group of immunomodulators, used to treat MS expire is one of the features of the current development of medicine. Due to the fact that most of them belong to interferons- β , i.e. biologicals, or structurally close to nonbiological complex drugs, the authors discuss the need to conduct comparative clinical trials of the original drug and follow-on glatiramoids with measured endpoints that can be used to establish their efficacy, safety, and evidence for therapeutic equivalence in order to examine their potential interchangeability.

Highlights

  • Небиологические лекарственные средства сложного химического строения и их аналоги в патогенетической терапии рассеянного склероза: вопросы эффективности и безопасности при клиническом использовании

  • Due to the fact that most of them belong to interferons-β, i.e. biologicals, or structurally close to nonbiological complex drugs, the authors discuss the need to conduct comparative clinical trials of the original drug and follow-on glatiramoids with measured endpoints that can be used to establish their efficacy, safety, and evidence for therapeutic equivalence in order to examine their potential interchangeability

  • В последние годы отмечается тенденция к росту заболеваемости рассеянного склероза (РС)

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Summary

Introduction

Небиологические лекарственные средства сложного химического строения и их аналоги в патогенетической терапии рассеянного склероза: вопросы эффективности и безопасности при клиническом использовании. Обобщен опыт применения одного из основных оригинальных препаратов для лечения рассеянного склероза (РС) – глатирамера ацетата (ГА, Копаксон®-Тева) в крупных российских центрах по исследованию и лечению РС. Проведенный анализ клинических исследований свидетельствует об эффективности и благоприятном профиле безопасности препарата.

Results
Conclusion

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