Biosimilars: impact of biologic product life cycle and European experience on the regulatory trajectory in the United States.

@article{Ahmed2012BiosimilarsIO,
  title={Biosimilars: impact of biologic product life cycle and European experience on the regulatory trajectory in the United States.},
  author={Islah Ahmed and Ben Kaspar and Uma R Sharma},
  journal={Clinical therapeutics},
  year={2012},
  volume={34 2},
  pages={400-19}
}
BACKGROUND Biosimilars are defined as biologic products that are highly similar to reference products, notwithstanding minor differences in clinically inactive components, with no clinically meaningful differences between the biologic product and the reference product in terms of safety profile, purity, and potency. Due to the high cost of innovator biologics, as well as an increase in the number of these products reaching patent expiry, the development of a process for approving biosimilar… CONTINUE READING
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