Pharmacovigilance of Biosimilars

Drug related authorities such as European Medicines Agency (EMA), Food and Drug Administration (FDA), and Health Canada hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy. According to them, analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components, animal studies (including the assessment of toxicity), and a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) are sufficient to demonstrate safety, purity, and potency in one or more.

As clinical trial data are usually insufficient to identify rare adverse effects, the general pharmacovigilance requirements applied to biosimilars are the same as those for any biological medicine. 

  • Current problems in pharmacovigilance
  • Role of pharma industries in the improvement of pharmacovigilance system
  • Detection and evaluation of drug safety signals
  • Adverse drug reactions with pharmaceutical products
  • Good pharmacovigilance practice and pharmacoepidemiology

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