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JNCI Journal of the National Cancer Institute 2006 98(7):435-436; doi:10.1093/jnci/djj145
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© Oxford University Press 2006.

NEWS

EMEA Tackles "Generic" Biologic Drug Issues

Mary Rice

The first 10% of the full text of this article appears below.

The regulation of biosimilar drugs—generic copies of biotechnology-derived products—is one of the most contentious issues the European Medicines Agency (EMEA) has had to deal with in its 11-year existence. Not only is proving similarity of such products scientifically complex, but many interested parties are lobbying energetically on various issues surrounding biosimilar drugs. And with many patents on biotech drugs ready to expire, there is increasing pressure to find some way of licensing these products. The U.S. Food and Drug Administration is . . . [Full Text of this Article]


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