Current and Future Perspectives on the Development of Biosimilar Insulins for Diabetes Management

نویسنده

  • Andrew J Krentz
چکیده

• The European Medical Agency (EMA) has issued regulatory guidelines for the development of biosimilar insulins that emphasize pharmacokinetic/pharmacodynamic studies rather than efficacy evaluations. In the United States, biosimilar insulins are currently covered by the Food and Drug Administration’s (FDA) 505(b)(2) pathway permitting evaluation of the reference product. Current and Future Perspectives on the Development of Biosimilar Insulins for Diabetes Management

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تاریخ انتشار 2017