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Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia—Overview, Evolution, and Regulations Assessment
المؤلفون المشاركون
Bas, Tomas Gabriel
Oliu Castillo, Carolina
المصدر
العدد
المجلد 2016، العدد 2016 (31 ديسمبر/كانون الأول 2016)، ص ص. 1-12، 12ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2016-04-24
دولة النشر
مصر
عدد الصفحات
12
التخصصات الرئيسية
الملخص EN
The development of biological products has experienced continuous growth over the past three decades.
The expiration of patent protection for many biological medicines has led to the development of biosimilars in many countries around the world.
This paper reviews the literature on biosimilar drugs and covers their therapeutic status, clinical trials, approved biosimilars, and regulatory guidelines in Japan, South Korea, and Malaysia.
The literature suggests that biosimilars are comparable but not identical to the reference product.
They are not a generic version of an innovative product and do not ensure therapeutic equivalence.
Biosimilars present more challenges than conventional generics and their marketing approval is also much more complicated.
Guidelines for biosimilars were published in Japan in July 2009 by the Ministry of Health, Labour and Welfare (MHLW), in South Korea in March 2009 by the Ministry of Food and Drug Safety (MFDS), and in Malaysia in July 2008 by the National Pharmaceutical Control Bureau (NPCB).
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Bas, Tomas Gabriel& Oliu Castillo, Carolina. 2016. Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia—Overview, Evolution, and Regulations Assessment. BioMed Research International،Vol. 2016, no. 2016, pp.1-12.
https://search.emarefa.net/detail/BIM-1098258
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Bas, Tomas Gabriel& Oliu Castillo, Carolina. Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia—Overview, Evolution, and Regulations Assessment. BioMed Research International No. 2016 (2016), pp.1-12.
https://search.emarefa.net/detail/BIM-1098258
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Bas, Tomas Gabriel& Oliu Castillo, Carolina. Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia—Overview, Evolution, and Regulations Assessment. BioMed Research International. 2016. Vol. 2016, no. 2016, pp.1-12.
https://search.emarefa.net/detail/BIM-1098258
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1098258
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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