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並前往https://www.paho.org/hq/dmdocuments/2008/Actualidad%20en%20la%20Regulacion%20de%20Biosimilares-SEBs.pdf

Regulatory Evaluation of Biosimilars / Subsequent Entry ...

true GENERICS and should not be regulated under generic pharmaceuticals regulations where they exist. ▫ Biologics are not “identical” by definition.

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