New Zealand customs officials recently seized 14 injectable pens labelled as Fitaro and Orsema – semaglutide-based medications manufactured by Incepta Pharmaceuticals, a drugmaker from Bangladesh. These drugs, meant to provide an affordable alternative to Novo Nordisk’s Ozempic, underscore a surge in demand for lower-cost versions of the popular diabetes and weight loss medication.
Ozempic and its anti-obesity counterpart, Wegovy, contain semaglutide, a compound that effectively reduces blood sugar and promotes weight loss. With the market for semaglutide-based treatments expected to reach $150 billion by the early 2030s, unauthorised versions are finding their way into countries like the US, UK, and Australia.
Global distribution and regulatory concerns
Incepta’s medications, which are only authorised for sale in Bangladesh, have been shipped to 12 other markets, and regulators in multiple countries, including New Zealand, the US, and the UK, have intercepted or seized them. According to Medsafe, New Zealand’s medicines regulator, unapproved medications like Fitaro and Orsema may pose health risks due to uncertain quality control standards.
Though Novo Nordisk holds the global patent for semaglutide, countries classified as least developed, like Bangladesh, benefit from patent exemptions, allowing local manufacturers to produce semaglutide-based medications for domestic use. However, the spread of these copies internationally has raised concerns over potential health risks and the risk of unapproved versions circulating in the market.
Market dynamics and patent issues
Novo Nordisk, Europe’s most valuable company, is working to enforce its patent rights in countries like China, where some firms have manufactured and promoted semaglutide drugs for domestic and international sale. A recent appeal in China could determine whether Novo Nordisk maintains exclusive production rights in that market.
Meanwhile, regulators in other countries, including Russia, have introduced temporary patent exemptions that allow domestic manufacturing of semaglutide without Novo’s approval.
As demand for semaglutide drugs continues to grow, healthcare and regulatory authorities worldwide are ramping up efforts to monitor and manage the influx of unapproved semaglutide products. This regulatory vigilance is crucial in safeguarding public health and ensuring medication quality standards.