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. 

This session of the Asian Biosimilars 2018  looks into the future and FDA initiatives that have already been announced to include enhanced tracking and follow-up of post market issues, planned improvements in AERS, and pilots of new post market drug-monitoring strategies. Current challenges in pharmacovigilance, Adverse drug reactions with pharmaceutical products, Biosimilar guidelines for pharmacovigilance practice and pharmacoepidemiology are the points that shall be laid emphasis in this session.

  • 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

Related Conference of Pharmacovigilance of Biosimilars

Pharmacovigilance of Biosimilars Conference Speakers