This handbook describes the science and technology behind biosimilar medicines, how they are produced and regulated, and many specific questions surrounding them, namely:

  • the terminology used D the meaning of ‘quality, efficacy and safety’ and ‘comparability’
  • the purposes and methodologies of non-clinical and clinical tests and trials
  • the role of pharmacovigilance and risk management
  • the significance of immunogenicity
  • access to medicines, including the pharmaceutical practice of substitution
  • the importance of the identification of medicines
  • the interchangeability of medicines in medical practice

To view the handbook in Italian, please click here.
To view the handbook in German, please click here.
To view the handbook in Spanish, please click here.