Is pharmacovigilance of biologicals cost-effective?
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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.
KeywordsBiologicals Biosimilars Cost-effectiveness Pharmacovigilance
Conflicts of interest
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