Falsified Humira found in Germany

HumiraA parallel importer has discovered counterfeits of AbbVie's blockbuster Humira in the German supply chain.

The fakes of Humira (adalimumab) - the world's biggest-selling drug with turnover of $11bn last year from use in rheumatoid arthritis, psoriasis and several other indications - seem to originate in Poland and Turkey and bear a falsified batch number that has never been used by AbbVie.

The fraudulent batch number (4249XD18) is found on 40mg Humira pre-filled syringes bearing an expiry date of May 2016, according to information supplied by Germany's Paul Ehrlich Institute (PEI).

The batch number on the secondary packaging does not match that on the primary blisters, which have two labels, one stuck over the other. The top label has another false number (42497XD18) while those underneath had Turkish lettering and six different (authentic) lot numbers, said the PEI in a statement.

Lab testing has shown that the contents of the syringe was adalimumab in the correct dose, indicating that this may be a case of diversion or potentially some other form of falsification such as fraudulently extending an expiry date, although this has not yet been confirmed.

AbbVie said certificates accompanying the shipment were also forgeries.

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