Follow-on biologics: challenges of the "next generation".

@article{Schellekens2005FollowonBC,
  title={Follow-on biologics: challenges of the "next generation".},
  author={Huub Schellekens},
  journal={Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association},
  year={2005},
  volume={20 Suppl 4},
  pages={
          iv31-36
        }
}
The imminent patent expiration of many biopharmaceutical products will produce the possibility for generic versions of these therapeutic agents (i.e. biosimilars). However, there are a number of issues that will make approval of biosimilars much more complicated than the approval of generic equivalents of conventional pharmaceuticals. These issues centre on the intrinsic complexity of biopharmaceutical agents, which are recombinant proteins in most cases, and the heterogeneity of proteins… CONTINUE READING

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