کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5588326 | 1569034 | 2017 | 19 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
The rise of biosimilars: How they got here and where they are going
ترجمه فارسی عنوان
ظهور بیوسیمیلارها: چگونه آنها در اینجا و در کجا می روند
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کلمات کلیدی
موضوعات مرتبط
علوم زیستی و بیوفناوری
بیوشیمی، ژنتیک و زیست شناسی مولکولی
علوم غدد
چکیده انگلیسی
Biosimilars have become a subject of great interest in the past few years. The European Union and the United States are seeing an increasing number of biosimilar applications and approvals. The development of a biosimilar is significantly more complex and costly than a small molecule generic product. In the European Union, there has been a wider use of these medications compared to the United States. More biosimilars are gaining approval in the United States, and these products will likely alter the healthcare system in highly impactful ways. Understanding the regulatory process, the risks, and benefits will enable clinicians to be prepared and maximize the utility of these medications when they enter the market. This article introduces the concept of a biosimilar, discusses the regulatory process in the United States, and reviews the risks and benefits of these products.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Metabolism - Volume 75, October 2017, Pages 45-53
Journal: Metabolism - Volume 75, October 2017, Pages 45-53
نویسندگان
Dhiren Patel, Colin Gillis, Joseph Naggar, Amee Mistry, Christos S. Mantzoros,