Counterfeit diabetes pens identified in EU and UK

According to the European Medicines Agency (EMA), pre-filled pens falsely labelled as the type 2 diabetes medicine Ozempic (semaglutide, 1mg, solution for injection) have been identified at wholesalers in the EU and the UK.

The pens, with labels in German, originated from wholesalers in Austria and Germany. There are differences in the appearance between the falsified pen and the original pen. A picture of the falsified pen has been published by Germany’s Federal Institute for Drugs and Medical Devices (BfArM), EMA confirmed.

Ozempic: supply and falsification issues

News of the falsified diabetes pen arrived as there has been heightened demand for the medicine. This has resulted in a supply shortage, EMA highlighted.

The pens are manufactured by Novo Nordisk A/S. EMA stated that the pens have batch numbers, 2D barcodes and unique serial numbers from genuine Ozempic packs.

EU medicine packs have unique 2D barcodes and serial numbers to enable tracking via an EU-wide electronic system. The potential falsification was alerted after operators scanned the packs of the falsified Ozempic, and the serial numbers were shown to be inactive, EMA noted.

This counterfeiting issue follows BfArM reporting on 11 October 2023 that it had taken over coordinating the counterfeit diabetes drug Ozempic case. BfArM stated this was due to several federal states actively being involved in the case.

When the EMA made its statement on the issue on 18 October, there was no evidence that any falsified pens have been dispensed to patients from legal pharmacies; and neither were there any reports of harm to patients in relation to the counterfeit medicine.

According to the Medicines and Healthcare products Regulatory Agency (MHRA) all counterfeit pens identified at (two) UK wholesalers have been recalled; none of the pens have been supplied to UK patients.

Dr Alison Cave, MHRA Chief Safety Officer emphasised the importance for sourcing products from legitimate suppliers: “Buying semaglutide from illegally trading online suppliers significantly increases the risk of getting a product which is either falsified or not licensed for use in the UK.”