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

Related Conference of Pharmacovigilance of Biosimilars

July 03-05, 2017

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8th Asian Biologics and Biosimilars Congress

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7th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR

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6th International Conference and Exhibition on GMP, GCP & Quality Control

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World Congress on Antibiotics: R&D, Market

Atlanta, USA
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12th World Pharma Congress

Budapest, Hungary
October 16-18, 2017

11th World Drug Delivery Summit

(10 Plenary Forums - 1Event)
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10th International Conference and Exhibition on Biologics and Biosimilars

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4th European Biopharma Congress

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7th Global Mass Spectrometry Congress

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Pharmacovigilance of Biosimilars Conference Speakers

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