Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development.

@article{Cai2012ChallengesOD,
  title={Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development.},
  author={X Y Cai and Jeff Thomas and Constance Cullen and Dominique L Gouty},
  journal={Bioanalysis},
  year={2012},
  volume={4 17},
  pages={2169-77}
}
Imminent patent expiry for a number of biological products currently on the market (many of which are blockbusters) has created an increasing opportunity for the development of biosimilars in the biotechnology industry. The key for successful biosimilar development is to demonstrate biosimilarity to the originator drug. In addition to demonstrating the similarity of physical and chemical properties between biosimilar and originator compounds, regulatory agencies require that immunogenicity be… CONTINUE READING