EU, UK authorities crack down on fake versions of Novo Nordisk's Ozempic

As Novo Nordisk works to get a handle on sales of illicit semaglutide, British and European drug authorities are warning that they've discovered falsified Ozempic pens on their home turf.

The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday confirmed that pre-filled pens falsely labeled as Novo’s Type 2 diabetes med Ozempic (semaglutide 1mg) were identified at two local wholesalers. All relevant pens have been recalled and accounted for, with none of the illicit drugs making it to U.K. patients, the MHRA said in a release.

After investigating the issue, the MHRA has determined that the products were brought in from legitimate suppliers in Austria and Germany.

Now, the U.K. drug regulator says it’s working closely with regulatory partners in other countries to maintain the security of the wider supply chain.

Europe's drug regulator, the European Medicines Agency (EMA), confirmed in a separate release that the falsified pens indeed came from wholesalers in Austria and Germany. 

Despite the fact that the bunk Ozempic pens appeared to have authentic German packaging, the MHRA says there are “substantial differences” versus legitimate pens.

The issue is now being investigated by EU drug regulators and the police, EMA added. In the meantime, German and Austrian authorities have issued statements of noncompliance to the relevant wholesalers for not following required procedures.

Novo's anti-counterfeiting efforts

Novo Nordisk, for its part, has seen a “significant increase” in illegal online sales of semaglutide, a company spokesperson said over email.

“We work with a third party specialized in monitoring and taking down of illegal online offers to specifically address this, and have further reinforced this activity in 2023 to ensure an even broader reach,” she added.

That said, Novo recognizes there are limitations to this approach, so the company is running physical investigations where they’re warranted.

“Concretely, this means that, on certain cases, we work on the ground with specialized firms to identify the perpetrators of these crimes, ideally trying to identify the original manufacturer of the counterfeit products to ensure we can report this to the authorities for their enforcement,” the spokesperson said.

She noted patients can protect themselves from counterfeits by only buying medicines from legitimate sources with a prescription. 

The case of falsified Ozempic pens in the U.K. is just the latest issue in an ongoing counterfeit odyssey.

Back in late May, the FDA warned of illegal knockoffs of Novo’s Ozempic and Wegovy. Five weeks after that, Novo filed a wave of lawsuits against pharmacies in the U.S. that are producing the copycats. Specifically, the Danish drugmaker accused four companies of making compounded versions of its products that are not approved by the FDA.

In October, meanwhile, the U.S. FDA sent warning letters to Semaspace and Gorilla Healing to stop selling online versions of semaglutide and tirzepatide, Eli Lilly’s rival diabetes med that’s also angling for an approval in obesity this year.