Biosimilars--science, status, and strategic perspective.

@article{Kresse2009BiosimilarsscienceSA,
  title={Biosimilars--science, status, and strategic perspective.},
  author={Georg-Burkhard Kresse},
  journal={European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V},
  year={2009},
  volume={72 3},
  pages={479-86}
}
Biopharmaceuticals based on recombinant proteins have started to go off-patent, opening the way for other manufacturers to place follow-on products to the market. Meanwhile it has been recognized by all stakeholders that there are fundamental differences between conventional small-molecule based drugs and biopharmaceuticals. This has led to the adoption of distinct legal and regulatory frameworks for biosimilars (follow-on products to biopharmaceuticals) in various parts of the world. This… CONTINUE READING

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