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EU turns down biotech generic

Industry watching FDA anxiously as Sandoz fights EMEA ruling on generic growth hormone

Edward Winnick(Edw10024@yahoo.com)

The generic drug industry is awaiting guidance from the US Food and Drug Administration (FDA) on how to proceed with testing and filing for approval of generic biotech drugs, following the European Commission's rejection last week of the world's first biogeneric.

How regulatory authorities deal with these types of drugs has become an important issue for the pharmaceutical industry, as several older biotech drugs near the end of their patent term. Agencies in the European Union and United States have been trying to hammer out regulations governing the approval of generic biotechnology drugs, which are more difficult to make than standard synthetic drugs. But last week's decision by the commission may be a signal that they aren't sure yet how to handle such products.

Sandoz, the world's second largest generics firm and a unit of Swiss pharmaceutical company Novartis AG, filed suit late last week against the European Commission...

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