19/20 March 2024
Following the recent concerns that falsified batches of Ozempic® may have entered the market, the Official Medicines Control Laboratory (OMCL) Chemisches und Veterinäruntersuchungsamt (CVUA, Karlsruhe, Germany) has determined that suspected batches of Ozempic® pre-filled pens contained insulin glulisine instead of the claimed active substance, semaglutide.
Ozempic® is a medicinal product authorized to treat type 2 diabetes, but it has also become a popular weight-loss treatment. This off-label use for weight-loss has currently led to shortages in the legal supply chain, making it a prime target for falsification. Since October 2023, authorities from several countries have issued warnings concerning dangerous falsified versions of Ozempic® pens, which if used could have life-threatening consequences, including hypoglycaemic shock and coma.
Using liquid chromatography coupled with high-resolution mass spectrometry (LC-HRMS) and nuclear magnetic resonance spectroscopy (NMR), the Chemical and Veterinary Investigation Office in Karlsruhe has now been able to demonstrate that the injection solution in the suspected falsified pre-filled syringes (PFS) contained the active substance insulin glulisine and not semaglutide, the active substance in Ozempic®.
More Information is available in the EDQM Newsroom.