کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
6086355 1207177 2014 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
9The biosimilar road in inflammatory bowel disease: The right way?
ترجمه فارسی عنوان
9 راه جالب در بیماری های التهابی روده: راه درست؟
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی غدد درون ریز، دیابت و متابولیسم
چکیده انگلیسی

The biologicals have led to dramatic changes in the management of immune-mediated diseases, and the subsequent development of their biosimilars may reduce the high costs of these agents. However, there remain concerns about the true equivalence of a biosimilar and its reference product, as well as around immunogenicity of these agents in IBD, although studies on rheumatoid arthritis support the similarity of biosimilars and their originators. Many of the biologicals are approved for multiple indications, but it is not always possible to extrapolate across indications for the corresponding biosimilars. For both reference agents and biosimilars, rare adverse events and long-term efficacy and safety can only be assessed through post marketing surveillance; therefore, particular emphasis should be placed on the traceability of these agents in clinical practice. Lastly, based on current data, biosimilars cannot be considered simple substitutes of reference products in IBD, unless demonstrated by well-designed randomized controlled trials.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Best Practice & Research Clinical Gastroenterology - Volume 28, Issue 3, June 2014, Pages 465-471
نویسندگان
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