Drug Development and Potential Regulatory Paths for Insulin Biosimilars.

@article{Minocha2014DrugDA,
  title={Drug Development and Potential Regulatory Paths for Insulin Biosimilars.},
  author={Mukul Minocha and Jogarao V. S. Gobburu},
  journal={Journal of diabetes science and technology},
  year={2014},
  volume={8 1},
  pages={14-19}
}
Under the Biologics Price Competition and Innovation Act (BPCI Act), a biological product may be demonstrated to be "biosimilar" if data show that, among other things, the product is "highly similar" to an already-approved biological product. Biosimilar insulins have the potential to reduce ever growing costs associated with insulin treatment by allowing… CONTINUE READING