An Overview of Current Regulatory Requirements for Approval of Biosimilar Insulins

  title={An Overview of Current Regulatory Requirements for Approval of Biosimilar Insulins},
  author={Lutz Heinemann and Hootan Khatami and R S Mckinnon and Philip Home},
  booktitle={Diabetes technology & therapeutics},
Insulin analog patent expiry is likely to mean that, increasingly, copies of original biopharmaceutical products will be submitted for authorization. Experience with biosimilars in other therapeutic areas suggests that careful regulation and caution are needed. Published guidelines of regulatory authorities around the world on approval of biosimilars and, where available, insulin biosimilars were reviewed. Information was sourced through Internet searching and cross-referencing guidelines. As… CONTINUE READING

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