FDA voices concern over bills that restrict biosimilars

08/30/2013 | Drug Store News · BioPharmaReporter.com

Biosimilars face a very high standard for approval, and efforts in state legislatures to undermine faith in the process that will bring them to market could hurt patients in the long run, FDA spokeswoman Lisa Kubaska said. Although the agency doesn't take stands on specific state measures, any biosimilars that are approved must be interchangeable products under a 2010 federal law, she said.

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Drug Store News · BioPharmaReporter.com

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