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New Alternatives for Autoimmune Disease Treatments: Physicochemical and Clinical Comparability of Biosimilar Etanercept
المؤلفون المشاركون
López-Morales, Carlos A.
Miranda-Hernández, Mariana P.
Ramírez-Ibáñez, Nancy D.
Perdomo-Abúndez, Francisco C.
Revilla-Beltri, Jorge
Molina-Pérez, Aarón
Salazar-Flores, Rodolfo D.
Pérez, Néstor O.
Medina-Rivero, Emilio
Flores-Ortiz, Luis F.
المصدر
Journal of Immunology Research
العدد
المجلد 2016، العدد 2016 (31 ديسمبر/كانون الأول 2016)، ص ص. 1-9، 9ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2016-06-12
دولة النشر
مصر
عدد الصفحات
9
التخصصات الرئيسية
الملخص EN
Etanercept is a recombinant fusion protein approved for the treatment of TNF-α mediated diseases such as rheumatoid arthritis (RA), psoriasis, psoriatic arthritis, and ankylosing spondylitis.
Herein, we present an evaluation of the physicochemical and biological properties of a biosimilar etanercept and its reference product followed by a clinical study in patients diagnosed with RA intended to demonstrate comparability of their immunomodulatory activity.
Identity analyses showed a total correspondence of the primary and higher-order structure between the two products.
In regard to intrinsic heterogeneity, both products showed to be highly heterogenous; however the biosimilar etanercept exhibited similar charge and glycan heterogeneity intervals compared to the reference product.
Apoptosis inhibition assay also showed that, despite the high degree of heterogeneity exhibited by both products, no significant differences exist in their in vitro activity.
Finally, the clinical assessment conducted in RA-diagnosed patients did not show significant differences in the evaluated pharmacodynamic markers of both products.
Collectively, the results from the comparability exercise provide convincing evidence that the evaluated biosimilar etanercept can be considered an effective alternative for the treatment of RA.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Miranda-Hernández, Mariana P.& López-Morales, Carlos A.& Perdomo-Abúndez, Francisco C.& Salazar-Flores, Rodolfo D.& Ramírez-Ibáñez, Nancy D.& Pérez, Néstor O.…[et al.]. 2016. New Alternatives for Autoimmune Disease Treatments: Physicochemical and Clinical Comparability of Biosimilar Etanercept. Journal of Immunology Research،Vol. 2016, no. 2016, pp.1-9.
https://search.emarefa.net/detail/BIM-1108922
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Miranda-Hernández, Mariana P.…[et al.]. New Alternatives for Autoimmune Disease Treatments: Physicochemical and Clinical Comparability of Biosimilar Etanercept. Journal of Immunology Research No. 2016 (2016), pp.1-9.
https://search.emarefa.net/detail/BIM-1108922
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Miranda-Hernández, Mariana P.& López-Morales, Carlos A.& Perdomo-Abúndez, Francisco C.& Salazar-Flores, Rodolfo D.& Ramírez-Ibáñez, Nancy D.& Pérez, Néstor O.…[et al.]. New Alternatives for Autoimmune Disease Treatments: Physicochemical and Clinical Comparability of Biosimilar Etanercept. Journal of Immunology Research. 2016. Vol. 2016, no. 2016, pp.1-9.
https://search.emarefa.net/detail/BIM-1108922
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1108922
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
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تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر
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