The handbook describes the science and technology behind biosimilars, how they are produced and regulated and tries to answer specific questions surrounding them including:
• the terminology used and 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.

The handbook is intended to be a reference source for, among others, patients, patient advocacy groups, pharmacists, physicians and prescribers, as well as for payers, politicians and policymakers.

The handbook is available in English, German, Italian and Spanish.

A more detailed discussion of how biosimilars are important for patients will be presented in the next article.

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