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Controversial new biologic approved in US

Sandoz?s recombinant human growth hormone gets FDA okay, despite critics? concerns of inadequate testing

Aaron J. Bouchie
The US Food and Drug Administration approved on Tuesday (May 30) a controversial drug some experts say is the first biogeneric, despite critics' concerns that the company did not perform adequate safety testing. However, the agency cautions that the approval should not open any doors for biogenerics.The product, a recombinant human growth hormone (rhGH) marketed as Omnitrope by Sandoz, has been called a biogeneric because its active ingredient in Omnitrope is somatropin, the same as in Pfizer's Genotropin, another recombinant human growth hormone that has been on the market since 1998. In addition, Sandoz submitted its application through a process that is normally used for generic drugs.However, in its approval document, the FDA calls Sandoz's Omnitrope a "follow-on protein product," not a biogeneric, and says its approval "does not create a new pathway for follow-on versions of all protein products." Unlike with other generics, patients can't...

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