Ukrainians admit selling fakes of Merck’s Keytruda in US

Two Ukrainian men have admitted to selling counterfeit cancer drugs in the US, including knock-offs of Merck & Co’s big-selling cancer immunotherapy Keytruda.

Maksym Nienadov (36) – the owner of a Ukrainian company called Healthy Nation – and employee Volodymyr Nikolaienko (33) pleaded guilty to conspiracy, trafficking in counterfeit drugs and smuggling goods into the US. Nienadov also admitted to introducing misbranded drugs into the US market.

Along with 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.

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.

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Nienadov and Nikolaienko were taken into custody in April 2019, after they arrived in the US from Ukraine “to discuss future unlawful shipments of pharmaceuticals,” according to a Department of Justice statement.

The two men are due to be sentenced on 4 November, it says.

The case is another example of counterfeiters falsifying high-value pharmaceutical products in the interest of making a quick profit, regardless of the consequences on people’s health.

Often, counterfeit medicines don’t contain the active ingredient promised on the label, and can also contain contaminants that can cause toxicity or infection – particularly in the case of drugs like Keytruda and Abraxane that are administered by intravenous infusion.

Keytruda is on course to become the top-selling drug in the world in the next few years, topping $11bn in sales last year and expected to top $14bn this year thanks to a steady stream of new approvals.

A few years ago, falsified cancer medicines hit the headlines after a notorious case in which fake copies of Roche’s antibody drug Avastin (bevacizumab) was purchased by nearly 100 US physicians and is thought to have been administered to patients.