Biogeneric Epo approved by EU

Novartis' generic drug arm Sandoz has scored a key victory in the drive for biosimilars. The EU has approved its biogeneric epoetin alfa for patients with renal anemia and those receiving chemotherapy. The decision is likely to add pressure on lawmakers and the FDA to come up with a well defined regulatory pathway for biosimilars in the U.S. Biotech lobbyists have argued strenuously that biologics are too complex to warrant any kind of generic drug process similar to that allowed for traditional drugs. But as European regulators approve more and more of these applications, they will continue to demonstrate that not all biologics are created with equal complexity.

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