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)
Summary
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.
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