E.U. Trumps FDA In Approval Of Biologics

Law360, New York (February 1, 2006, 12:00 AM EST) -- In a sign the United States and the European Union will soon be on different playing fields when it comes to generic biotechnology drugs, the European Commission has moved to grant Sandoz GmbH authority to sell human growth hormone Omnitrope, the first approved “biologic.”

The European Medicines Agency (EMEA) said biologics may now be authorized on the basis of appropriate non-clinical and clinical data requirements. That’s the same basis for approval Sandoz has sought in the United States, using provision 505(b) of the 1984 Hatch Waxman...
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