More falsified Velcade discovered in Europe

Parallel import companies have discovered four falsified batches of the cancer drug Velcade in the European supply chain.

The falsified batches of Janssen-Cilag's drug – which is approved in Europe to treat the serious blood cancer multiple myeloma – were uncovered by parallel traders in Denmark and the Netherlands, and in all cases the vials they contain do not appear to be made by the genuine manufacturer, with variations in the vial type and seal, according to the German drugs regulator BfArM.

Danish company Abacus Medicines intercepted three batches of Velcade 3.5mg/vial – with the numbers GGZT800 (expiry date 06/2019), GCZTQ00 (02/2019) and FGZSL01 (06/2018) – while Dutch firm Axicorp Pharma BV identified a fourth batch FJZT800 with an expiry of 09/2018. The batches mimic genuine product distributed in Bulgaria and Romania, but the folding carton, vial labels and package inserts are all forged.

Interestingly, laboratory testing indicates the vials from the batches contain the active ingredient of Velcade – bortezomib – at the levels and specifications indicated on the label, suggesting the counterfeiters have taken lengths to source the drug and mask their activity. The methods used are unclear, but could involve sourcing cheaper generic versions of the drug, or repackaging expired product for example.

Last month, BfArM reported that a German parallel importers ACA Muller ADAG Pharma and Hvd Medical, and another Dutch importer Dr Fisher Farm, had identified additional Velcade counterfeits carrying the same three batch numbers and expiry dates indicated above.

The regulator advises wholesalers, pharmacists and physicians to examine the packs and batch identifiers of Velcade before application and to report any suspected cases of falsification.

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