Pharmacovigilance on biologicals and biosimilars: A Danish perspective

Abstract

The development of biological medicinal products is in rapid growth and as patents for reference products expire, new biosimilar products become available. This has a marked impact on several stakeholders; from patients and physicians to decision-makers, and on activities; from treatment of patients to the conduct of pharmacovigilance. The Danish Medicines Agency (Laegemiddelstyrelsen, DKMA) has increased its focus on the pharmacovigilance of biologicals and is implementing an action plan jointly with a working group comprising representatives from the Danish Medical Association, the pharmaceutical industry and the five Danish regions.