کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2578765 | 1130013 | 2015 | 9 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Biosimilars: from Technical to Pharmacoeconomic Considerations
ترجمه فارسی عنوان
بیوسیمیلار: از نظر فنی به ملاحظات دارویی
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کلمات کلیدی
HASLFSSCNAMCEPSLEEMCNILCSISANSMGCSFSMRASMREMIEPOEMACME - آموزش مداومEuropean Medicines agency - آژانس دارویی اروپاGross domestic product - تولید ناخالص داخلیGDP - تولید ناخالص ملیSubstitution - جایگزینیTraceability - قابلیت ردیابیMarketing authorization - مجوز بازاریابیRisk management - مدیریت ریسکHealth care costs - هزینه های مراقبت های بهداشتیEPAR - کبدCOMEDIMS - کمدیEuropean Public Assessment Report - گزارش ارزیابی عمومی اروپا
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
فارماکولوژی، سم شناسی و اقلام دارویی (عمومی)
چکیده انگلیسی
A biosimilar is a biological medicinal product claimed to be similar to a reference biological medicinal product. Its development plan includes studies comparing it with the reference product in order to confirm its similarity in terms of quality, preclinical safety, clinical efficacy, and clinical safety, including immunogenicity. Biosimilars differ from generics both in their molecular complexity and in the specific requirements that apply to them. Since patents on many biological medicinal products will expire within the next 5 years in major therapeutic areas such as oncology, rheumatology and gastroenterology and as those products are so costly to the French national health insurance system, the availability of biosimilars would have a considerable economic impact. The round table has issued a number of recommendations intended to ensure that the upcoming arrival of biosimilars on the market is a success, in which prescribing physicians would have a central role in informing and reassuring patients, an efficient monitoring of the patients treated with biologicals would be set up and time to market for biosimilars would be speeded up.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Thérapie - Volume 70, Issue 1, JanuaryâFebruary 2015, Pages 47-55
Journal: Thérapie - Volume 70, Issue 1, JanuaryâFebruary 2015, Pages 47-55
نویسندگان
Danièle Girault, Jean-Hugues Trouvin, Corinne Blachier-Poisson, François Gary, Didier Laloye, participants of round table N°3 of Giens XXX: participants of round table N°3 of Giens XXX:, Jean-François Bergmann, Nicole Casadevall, Cécile Delval,