Another EU fake Velcade alert, this time in Finland

Finnish medicines regulator Fimea has issued a warning against prescribing Janssen-Cilag’s cancer drug Velcade in hospital pharmacies after discovering counterfeits.

The falsified batches were identified among Velcade (bortezomib 3.5mg powder for injection) packs imported into the country by parallel distributor Orifarm Oy, and the regulator says this formulation is used in hospitals only.

Nine packs of the suspect drug were used to treat patients before the falsification was identified, according to Fimea, although it says there do not seem to be any unexpected adverse reactions from their use.

The Finnish suspension comes after a string of incidents involving suspected counterfeit Velcade in European countries, often discovered during repackaging by parallel importers. Germany, the Netherlands and Denmark all reported cases last year in which the suspect batches seemed to contain the right active ingredient at the right level, but with falsified packaging.

That may also be the case with the batch found in Finland, with Fimea noting that the drugs are “suspected of being inaccurate at least as regards the labelling of the drug.” It has been speculated that the falsification could involve substitution of cheaper, generic copies of the drug, re-labelling expired, genuine Velcade vials or an attempt to introduced stolen material into the supply chain.

Fimea says this is the second known occasion in which a counterfeit medicine has been introduced into the legitimate medicines supply chain in Finland - four years ago fakes of another drug used in hospitals – Roche’s breast cancer therapy Herceptin (trastuzumab) – were also discovered in the country as well as in the UK and Germany.