Pharmacovigilance of biologicals in Denmark

Biosimilars/Research | Posted 19/08/2016 post-comment0 Post your comment

As a result of the increasing use of biologicals and biosimilars in Denmark, the Ministry of Health (MoH) in partnership with the country’s regulatory agency has set up an action plan to monitor biologicals and improve pharmacovigilance, as well as to improve understanding among healthcare professionals and patients [1].

Pharmacovigilance V13F21

The Action Plan on Biological Medicines, Biosimilars and Vaccines for 2015–2016 has been set up by the MoH and the Danish Medicines Agency (Laegemiddelstyrelsen, DKMA) to ensure targeted and product-specific monitoring of biologicals. It focuses on four key areas:
• Undertaking activities to encourage monitoring of biologicals at the product level
• Carrying out information activities to improve healthcare professionals’ understanding of product-specific monitoring and ‘peace of mind’ among patients when using the products
• Offering digital solutions at hospitals and in medical practices to ease adverse drug reaction reporting from healthcare professionals
• Increasing focus within the DKMA on monitoring the safety of using biologicals and biosimilars

To improve monitoring two executive orders came into effect on 1 January 2016. These require that healthcare professionals make records of the brand name and batch number in patient health records when prescribing any biological medicine. They also make it mandatory for healthcare professionals to include, where possible, the brand name and batch number when reporting suspected adverse drug reactions (ADRs).

Another initiative focusses on raising awareness on biosimilarity through targeted information. So far this has included carrying out a meeting with patient organizations and providing information on the DKMA website.

The action plan on biologicals and biosimilars will be evaluated by the end of 2016.

Editor’s comment
This article for GaBI Online is a summary of the full manuscript published in GaBI Journal.

If you would like to receive a copy* of the GaBI Journal manuscript [1], please send us an email

Readers interested to learn more about pharmacovigilance of biosimilars are invited to visit to view the following manuscript published in GaBI Journal:

Pharmacovigilance of biosimilars: challenges and possible solutions

If you are interested in contributing a research article in a similar area to the GaBI Journal, please send us your submission here

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1. Lunddahl B. Pharmacovigilance on biologicals and biosimilars: a Danish perspective. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(3):123-4. doi:10.5639/gabij.2016.0503.030

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