Abstract
Pharmacovigilance is an essential part of the post-marketing surveillance of new biologicals. It not only requires a substantial investment of the marketing authorization holder but also of the clinical field to provide accurate safety information. Hence, does pharmacovigilance delivers value for money? This important question needs to be discussed in the light of regulatory requirements, value and cost.
Keywords:
Biologicals; Biosimilars; Cost-effectiveness; Pharmacovigilance.
MeSH terms
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Adverse Drug Reaction Reporting Systems / economics*
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Adverse Drug Reaction Reporting Systems / legislation & jurisprudence
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Biological Products / adverse effects*
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Biosimilar Pharmaceuticals / adverse effects*
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Cost-Benefit Analysis
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Drug Costs
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Drug and Narcotic Control / economics*
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Drug and Narcotic Control / legislation & jurisprudence
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Drug-Related Side Effects and Adverse Reactions / diagnosis
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Drug-Related Side Effects and Adverse Reactions / economics
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Drug-Related Side Effects and Adverse Reactions / epidemiology*
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Health Care Costs* / legislation & jurisprudence
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Humans
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Patient Safety / economics*
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Patient Safety / legislation & jurisprudence
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Pharmacovigilance*
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Policy Making
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Risk Assessment
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Risk Factors
Substances
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Biological Products
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Biosimilar Pharmaceuticals