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Y_A

Re: None

Tuesday, 05/26/2009 4:36:12 AM

Tuesday, May 26, 2009 4:36:12 AM

Post# of 20689
THE EMEA HAS ISSUED GUIDELINE ON NON-CLINICAL AND CLINICAL DEVELOPMENT OF SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING
LOW-MOLECULAR-WEIGHT-HEPARINS

http://www.emea.europa.eu/pdfs/human/bio...

If I understand correctly it is regarded as a bioimilar (~FOB) and not a regular generic as is it in the US. This makes the whole process more complicated and clinical trials should be conducted....

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