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 incorporate enhanced tracking and follow-up of post marketing surveillance issues, and on FDA initiative planned different changes in AERS, pilots of latest developed post market strategies of drug-monitoring and ADR related problems. the rules of biosimilars for pharmacovigilance and pharma epidemiology are the points that shall be laid emphasis within the session In USA average annual income mostly spend on biologics comparing to generic drugs for example:16% on biologics and three on other drugs.


  • Manufacturing methods
  • Product names
  • Generics and brand name products
  • Postapproval surveillance for immunogenicity
  • Evolving guidelines

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