More than a year ago, New Zealand customs officials began intercepting several batches of injections marked with the brands Fitaro and Orsema, produced by the little-known Bangladeshi pharmaceutical company Incepta Pharmaceuticals.
According to documents seen by Reuters, data provided by New Zealand's drug regulatory authority, Medsafe, showed that 14 injection pens seized at the border contained semaglutide, a patented substance that helps control blood sugar levels and appetite and is a key ingredient in Novo Nordisk's best-selling drugs Ozempic and Wegovy.
Reuters found that against the backdrop of a surge in global demand for Ozempic, Incepta's drugs have become part of the Asian supply chain, producing and exporting cheap generic versions of Ozempic to countries around the world.
Ozempic is developed for patients with type 2 diabetes, but its active ingredient semaglutide has also shown effectiveness in promoting weight loss. Novo Nordisk is targeting the anti-obesity drug Wegovy, with expectations that the market size for such weight loss drugs could reach $150 billion by the 2030s.
According to Reuters, at least 106,000 packs of semaglutide drugs produced by Incepta in Asia have been shipped to 12 foreign markets, including the United States and the United Kingdom, which are countries protected by Ozempic patents.
According to public records and information provided by a local regulatory official, Incepta did not respond to multiple requests for comment on Fitaro and Orsema. Both companies have been approved for sale in Bangladesh. The official from the Bangladesh Directorate General of Drug Administration said that Bangladeshi regulatory authorities have approved Incepta to export Fitaro or Orsema, but only if the company obtains approval from the receiving country. Due to not being authorized to speak to the media, the official declined to be named. Regulatory data shows that between August 2023 and May 2024, these injection pens, which were not authorized for use in New Zealand, were submitted to Medsafe and destroyed.
Related video: WeightWatchers launches an Ozempic version despite FDA concerns (WCVB Boston) WeightWatchers announced that it will now offer a version of Ozempic to qualified members.
Medsafe told Reuters that the destroyed batches of Fitaro and Orsema seemed to be intended for personal use, but did not comment on whether these drugs posed a health risk.
"Drugs imported from overseas will not have been assessed and approved by Medsafe, and therefore pose a significant risk because the quality cannot be guaranteed to meet acceptable levels," the regulator added in response to Reuters' inquiries about the importation of semaglutide drugs.
Reuters previously reported that semaglutide drugs from Bangladesh were being sold on the Indian online market IndiaMART. The latest report indicates that non-Novartis-produced semaglutide drugs are more widely distributed internationally.
Reuters' investigation data comes from drug regulatory authorities in Australia, Brazil, New Zealand, and the United States; information from commercial customs data providers in Kenya, Uzbekistan, Venezuela, Hong Kong, and the United Arab Emirates; and drug seizure records from the United Kingdom, Switzerland, and Ireland.
In addition, interviews with exhibitors at a trade exhibition, reviews of commercial customs data providers, and data from the Brazilian Ministry of Justice show that at least six little-known companies (four of which are based in Asia) produce semaglutide-based drugs and ship their products overseas.
According to commercial customs data providers, an interview with an employee of Nanjing Hanxin Pharmaceutical Technology Co., Ltd. in China, and a review of a website and social media application by Reuters, at least three of these companies import key ingredients from China, and at least one product is promoted online and in person outside the country of origin.
Reuters' reporting indicates that these companies have taken advantage of global patent exemptions allowed in less developed countries and lax patent enforcement in countries such as China.
Novo Nordisk told Reuters that as the only approved producer of semaglutide globally, the company cannot ensure the safety or effectiveness of products声称 to contain semaglutide from other manufacturers.
Although Novo Nordisk's semaglutide products are protected by international licenses, the least developed countries listed by the United Nations, such as Bangladesh and Laos, enjoy exemptions from industry patent rules. This Danish company has rapidly risen to become one of Europe's most valuable companies, with a market value of about $400 billion. The company stated on its official website that it does not enforce patent protection in developing countries. Given the strong market demand for Ozempic, potential patent infringement currently seems to have a limited financial impact on Novo Nordisk. Nicholas Anderson, portfolio manager and managing director at Thornburg Investment Management, an asset management company, pointed out: "Currently, illegal drugs do not pose a threat to Novo Nordisk's sales because they are selling every dose they can produce." The company holds shares in Novo Nordisk.
However, this practice of generics has raised concerns in the healthcare sector. According to records from drug regulatory authorities and responses to Reuters' inquiries, drug regulatory authorities in at least six countries, including the United States, the United Kingdom, and Ireland, have refused, destroyed, or seized some of Incepta's semaglutide drugs. In one case, according to an announcement by a local drug regulatory authority in January, unauthorized semaglutide was recalled in South Africa in December due to potential health risks. The authority told Reuters that the ingredient came from a Chinese supplier not authorized to produce Ozempic ingredients, but did not provide further details.
The announcement stated: "The semaglutide found in these unapproved substances may contain unexpected impurities or degradation products, which may have unknown effects on patients."
Reuters found no evidence that these products have harmed patients, but their circulation could exacerbate public health concerns about the medical industry.
