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DewDiligence

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DewDiligence

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Re: Y_A post# 290

Tuesday, 05/26/2009 6:02:41 AM

Tuesday, May 26, 2009 6:02:41 AM

Post# of 20689
Re: EMEA guidelines for biosimilar low-molecular-weight heparin drugs

Your link doesn’t work—the correct link is:
http://www.emea.europa.eu/pdfs/human/biosimilar/11826407enfin.pdf

If I understand correctly, it is regarded as a biosimilar (~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...

That’s correct. This is why NVS and MNTA have not already submitted a biosimilar Lovenox application in the EU. The companies are studying the EMEA guidelines set forth in the above link to determine whether submitting an application is a worthwhile business proposition (#msg-37264016). Regards, Dew


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