کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2771286 1151732 2016 10 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Biosimilars: Rationale and current regulatory landscape
ترجمه فارسی عنوان
بیوسیمیلار: منطق و چشم انداز نظارتی فعلی
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی بیهوشی و پزشکی درد
چکیده انگلیسی

ObjectivesTo discuss current terminology and the regulatory standards and processes involved in the development of biosimilars.MethodsAn Internet-based literature search through April 2015 was performed for information related to biosimilars in chronic inflammatory disorders. Keywords were as follows: biosimilar, development, manufacturing, characterization, structural, functional, preclinical, clinical, immunogenicity, rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, Crohn׳s disease, ulcerative colitis, and ankylosing spondylitis. The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) websites were searched for guidelines and information related to biosimilars.ResultsBiosimilars are products that are highly similar to the reference product regarding quality, biological activity, safety, and efficacy. Biosimilars are biological products and not generic drugs and, thus, do not follow the same regulatory pathways as generic molecules. Rigorous early-stage structural, functional, and analytical testing, followed by nonclinical and clinical analyses comparing a biosimilar with its reference product, are required to demonstrate biosimilarity in regulatory markets worldwide.ConclusionsThe addition of biosimilars to the market has the potential to improve access to biologic therapies. Many regulatory agencies have enacted stringent pathways, which must be followed for a biosimilar to be labeled and approved as such; following the pathways will help protect and maintain the integrity, quality, and safety of the biosimilar product.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Seminars in Arthritis and Rheumatism - Volume 45, Issue 5, Supplement, April 2016, Pages S1–S10
نویسندگان
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