Counterfeit Keytruda traffickers sentenced in US

Two Ukrainian nationals have been sentenced to prison terms in the US for trafficking and smuggling counterfeit cancer and hepatitis medicines into the US, including fakes of Merck & Co's big-selling cancer immunotherapy Keytruda.

Maksym Nienadov (36) – the owner of the Ukraine-based company Healthy Nation – and co-conspirator and employee Volodymyr Nikolaienko (34) pleaded guilty last July to the charges, while Nienadov also admitted introducing misbranded drugs into US commerce.

Nienadov was sentenced to 71 months in federal prison, while Nikolaienko received 33 months, and are both expected to be deported after their sentences are completed.

Along with Merck's Keytruda (pembrolizumab), the men also admitted unlawfully selling counterfeits of Bristol-Myers Squibb/Celgene’s cancer drug Abraxane (nab-paclitaxel) as well as Epclusa (sofosbuvir/velpatasvir), a treatment for hepatitis C virus marketed by Gilead Sciences.

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US enforcement agencies started investigating the pair in 2018, spending thousands of dollars on test purchases of all three medicines that Nienadov and Nikolaienko were offering for sale.

On receipt of the products, the samples were sent to the drug manufacturers for testing, and the packages and contents of all of them were found to be counterfeit. Nienadov and Nikolaienko were arrested in April 2019 after they arrived in the US from Ukraine to discuss sales of future unlawful shipments of drugs.

"The defendants sought to profit off the illnesses of others, selling false hope – including fake drugs with no active ingredient – and risking the health of vulnerable patients," said Acting Assistant Attorney General Nicholas McQuaid of the US Justice Department’s Criminal Division.

"This prosecution makes clear that we will hold accountable those who disregard the risks to patients by smuggling counterfeit drugs into the US,” he added.