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العنوان
Biosimilars and small molecule drugs/
الناشر
Ain Shams university.
المؤلف
Soliman ,Hatem Mohammed Hassan.
هيئة الاعداد
مشرف / داليا عبد المحسن حسين
مشرف / حنان محمد فاروق
مشرف / شفيقة ابراهيم ابراهيم
باحث / حاتم محمد حسن سليمان
الموضوع
Biosimilars. small molecule. drugs.
تاريخ النشر
2012.
عدد الصفحات
P .138 :
اللغة
الإنجليزية
الدرجة
ماجستير
التخصص
الروماتيزم
تاريخ الإجازة
1/1/2012
مكان الإجازة
جامعة عين شمس - كلية الطب - Rheumatology
الفهرس
Only 14 pages are availabe for public view

from 138

from 138

Abstract

The biologic agents are specifically engineered molecules designed to block particular immunologic activation steps involved in the pathogenesis of diseases such as rheumatoid arthritis or psoriasis. These conditions involve the actions of various cellular components, including lymphocytes, macrophages and B cells, and secreted compounds, such as interleukins, tumor necrosis factor, and other cytokines.
Biosimilars, also known as ’biogenerics’, ’follow-on proteins’ or ’follow-on biologics’, are approved new versions of innovator biopharmaceutical products developed following patent expiry. They are distinct from generic drugs, defined by the FDA as drugs that are identical or within an acceptable bioequivalent range to the small molecule innovator drug with equal dose, strength, safety, efficacy, intended use and method of administration. Unlike the more widespread generic small molecule drugs, biosimilars are large molecules that are produced by living organisms and exhibit high molecular complexity. In contrast to small molecule generics produced by chemical synthesis offering high levels of stability, biosimilar molecules are very sensitive to the slightest manufacturing process changes.Following a surge in the use of biologics in hard-to-treat disease areas, such as rheumatology, oncology and other chronic diseases, reflected in an industry prediction that biopharmaceuticals will soon make up 50% of new drug approvals, there has been a significant rise in interest in the field of biosimilars. The possibility of marketing new versions of existing biopharmaceuticals whose patents have expired is becoming increasingly attractive to manufacturers, particularly as more innovator products come off patent over the coming years. Small molecules are low molecular weight compounds that have a potent biological effect. Small molecules typically bind to cellular structures such as surface receptors, intracellular signalling proteins and enzymes with subsequent modulation of their function.The successful application of small molecule kinase inhibitors in oncology provides a tremendous insight into the signal transduction therapy and creates a foundation for the extension of the application of small molecules to rheumatology. There are currently a significant number of small molecule drugs in the pipeline for treatment of inflammatory diseases, with some promising molecules such as Jak-Stat and Syk inhibitors on the horizon.