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Why Biosimilars Are More and More Popular?

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神经达人 发表于 2015-11-19 15:47:30 | 显示全部楼层 |阅读模式
Biosimilars refer to the copy of the drug in the dose, safety and potency (regardless of how to take), quality, function, and adaptation.

The United States Pure Food and Drug Administration (FDA) documents point outthat FDA approval to the biosimilars can be obtained if the biosimilars:
» Contain the same active ingredients with the imitated drug products, while the non active ingredients can be different;
»Comply with the copied drugs in indications, dosage form, specification, the route is consistent;
»Are bio-equivalent with the corresponding drugs;
» Meet the same requirements with the copied drugs;
» Follow the same strict GMP standards with the imitated products.

Biosimilars coexist with original research drugs in developed countries. So why all countries, no matter developed pr developing, are developing the non-patented drugs production?


debbieevans 发表于 2015-11-26 14:05:18 | 显示全部楼层
Drug production is a huge potential industry, so it is hot in both developed countries and non - developed countries.




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