Clinical Studies on Biosimilars

In innovative drug development, three phases, and usually multiple studies per phase, of clinical research are required. In contrast, biosimilar clinical development can be abbreviated because of the breadth of understanding of the reference biologic and if the structural or functional similarity of the biosimilar has been preliminarily demonstrated analytically.  While clinical requirements differ by regulatory agency, in general, two phases of clinical studies are required – a Phase I study to demonstrate similar pharmacokinetics (how a medicine moves through the body) and a Phase II study of pharmacodynamics (effect of the medicine in the body), along with a pivotal study, referred to as Phase III, to demonstrate similar efficacy, safety and immunogenicity to the reference biologic.

  • Extrapolation of Indications in Biosimilars
  • Biosimilars Clinical Trials
  • Toxicological studies
  • Clinical PK/PD studies
  • Targeted cell line development
  • Transgenic animals
  • Case studies and clinical models
  • Risk management and quality affairs
  • Clinical trials on major diseases
  • Biosimilars Clinical Studies
  • Aspects of genotoxicity tests

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