Pharmacovigilance challenges in Biosimilars

Same proportion pharmacovigilance for biosimilars has comparatively more different from other products. Biosimilars 2019 session mainly look that have already been announced to include enhanced tracking and follow-up of post marketing surveillance issues, and on FDA initiative planned different changes in AERS, pilots of new developed post market strategies of drug-monitoring and ADR related problems. The guidelines of biosimilars for pharmacovigilance and pharma epidemiology are the points that shall be laid emphasis in the session In USA average annual income mostly spend on biologics comparing to generic drugs for example:16% on biologics and 3% on other drugs.

  • Adverse drug reactions with biologics and biosimilar products
  • Detection and evaluation of drug safety signals
  • Role of Pharma industries in the improvement of pharmacovigilance system
  • Good pharmacovigilance practice and pharmacoepidemiology

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