By Andrew Silver
SHANGHAI (Reuters) – Simply over a 12 months in the past, New Zealand customs officers began to intercept batches of injectable drugs labelled Fitaro and Orsema, developed by a little-known Bangladeshi drugmaker, Incepta Prescription drugs.
The injectable pens, 14 of which have been seized on the border, contained semaglutide, a patented substance that helps management blood sugar ranges and urge for food and is the important thing ingredient in Novo Nordisk (NYSE:)’s blockbuster medication Ozempic and Wegovy, in line with information from New Zealand’s medicines regulator Medsafe, reviewed by Reuters.
The Incepta medication are a part of an Asia-based provide chain manufacturing and exporting cheaper copies of Ozempic internationally, Reuters has discovered, pushed by a spike in world demand for the drug.
Ozempic was developed for kind 2 diabetes however its energetic ingredient semaglutide is efficient in selling weight reduction. The marketplace for such weight-loss remedies, which Novo Nordisk is focusing on with anti-obesity therapy Wegovy, is forecast to achieve $150 billion by the early 2030s.
In response to a Reuters evaluate, no less than 106,000 packs of semaglutide-based medicines made in Asia by Incepta have been shipped to 12 overseas markets together with international locations like the USA and Britain the place Ozempic is protected by patents.
Incepta didn’t reply to a number of requests for remark about Fitaro and Orsema, that are authorized on the market in Bangladesh, in line with public information and data supplied by a neighborhood regulatory official. The official with the Bangladesh Directorate Common of Drug Administration, who declined to be named as a result of he was not approved to talk to the media, mentioned Bangladeshi regulators had given Incepta permission to export Fitaro or Orsema however solely supplied it had received approval from receiving international locations. The injectable pens, which aren’t authorised to be used in New Zealand, have been referred to Medsafe between August 2023 and Could 2024 and destroyed, information from the regulator confirmed.
Medsafe informed Reuters the Fitaro and Orsema batches that have been destroyed seemed to be for private use however didn’t touch upon whether or not the medicines carried any well being danger.
“Medicines which were imported from abroad won’t have been assessed and authorized by Medsafe, so carry a major danger as there isn’t a assurance they’ve been made to an appropriate degree of high quality,” the regulator added in response to a Reuters question about imports of semaglutide-based medication.
Reuters has beforehand reported that semaglutide medication from Bangladesh have been offered on India-based on-line market IndiaMART. The newest reporting reveals that the worldwide distribution of semaglutide medication not made by Novo Nordisk is far wider.
The info surveyed by Reuters got here from pharmaceutical regulators in Australia, Brazil, New Zealand and the USA; data from a industrial customs information supplier for Kenya, Uzbekistan, Venezuela, Hong Kong and the United Arab Emirates; and information of intercepted medication from Britain, Switzerland and Eire.
As well as, an interview with a commerce present exhibitor, a evaluate of information from the industrial customs information supplier, and from Brazil’s Justice Ministry confirmed that six little-known firms, 4 of that are based mostly in Asia, manufacture semaglutide-based medicines and that their merchandise are shipped abroad.
A minimum of three of those companies imported the important thing ingredient from China and no less than one among their merchandise was promoted on-line and in particular person outdoors the nation of origin, in line with the industrial customs information supplier’s information, an interview with an worker at Chinese language provider Nanjing Hanxin Pharmaceutical Expertise, and an internet site and social media app reviewed by Reuters.
These gamers reap the benefits of world patent exemptions allowed for much less developed international locations and cases of free patent enforcement in international locations together with in China, the Reuters evaluate reveals.
Novo Nordisk informed Reuters it’s the solely authorized producer of semaglutide globally, and it couldn’t vouch for the protection or effectiveness of merchandise claiming to include semaglutide made by different producers.
Though Novo Nordisk’s semaglutide is protected by worldwide licences, international locations like Bangladesh and Laos, categorised as least developed nations by the United Nations, get pleasure from exemptions from trade patent guidelines.
The Danish agency, which has shortly turn out to be Europe’s most dear firm with a market capitalisation of round $400 billion, states on its web site that it doesn’t implement patents in much less developed international locations. Given the frenzied demand for Ozempic, the monetary influence of doable patent infringement on Novo Nordisk is at present restricted. “Unlawful variations of the medication at present don’t cannibalize Novo’s gross sales given they’re promoting each dose they’ll produce,” mentioned Nicholas Anderson, portfolio supervisor and managing director at world asset administration agency Thornburg Funding Administration, which owns Novo Nordisk shares.
Nonetheless, such copies are elevating healthcare considerations. Medicines regulators in no less than six international locations together with the U.S., Britain and Eire have rejected, destroyed or seized a few of Incepta’s semaglutide-based medication, in line with drug regulator information and responses from regulators to Reuters’ queries. In a single case, unauthorised semaglutide was recalled in South Africa in December, due to potential well being dangers, in line with a public discover posted in January by the native medicines regulator. The authority informed Reuters the ingredient was sourced from a provider in China not authorised to supply the ingredient in Ozempic, with out offering extra particulars.
“The semaglutide, mentioned to be discovered on this unauthorised substance, might include sudden impurities or degradation merchandise which might have unknown results on sufferers,” the discover mentioned.
Reuters discovered no proof that these merchandise would have brought on any hurt to sufferers, however their unfold may add to public well being considerations a couple of sector additionally threatened by faux Ozempic.
PARALLEL SUPPLY CHAIN
The official with the Bangladesh Directorate Common of Drug Administration mentioned Orsema was authorized in Bangladesh and thought of protected. Fitaro can also be authorized on the market, public information present.
A clinic within the capital Dhaka has prescribed Incepta’s Fitaro injector pens to round 20 sufferers, all foreigners based mostly in Bangladesh, in line with a supervisor, who declined to be named or determine the clinic because of the sensitivity across the therapy. “When sufferers came upon that Fitaro was accessible in Bangladesh at a most month-to-month price of round $60 a month, (towards) $650 within the U.S. (for Wegovy), they did not appear notably targeted on who the producer was,” the supervisor mentioned. In Laos, semaglutide-based medicines can solely be legally produced and distributed for nationwide use, Davone Duangdany, director of the drug and medical system management division throughout the Laos well being ministry, informed Reuters. However some Chinese language firms have been selling Laos-produced semaglutide tablets in China, the place Novo Nordisk’s patent is because of expire in 2026 or earlier if it loses a authorized problem. At an trade exhibition in Shanghai in June that Reuters attended, ingredient producer Nanjing Hanxin Pharmaceutical Expertise displayed containers of Semagcare semaglutide tablets, manufactured by Laos-based Boten Elemento Pharma.
Abdu Zoghbi, enterprise improvement director of Nanjing Hanxin, informed Reuters that his firm offers semaglutide to the Laos-based drugmaker.
“We do not know which international locations (Semagcare is offered to) however we’re doing the promotion as a result of as soon as they promote extra, we promote extra API (energetic pharmaceutical ingredient) to them,” he informed Reuters when requested about why it was showcasing the drug on the expo.
Boten Elemento Pharma’s Semagcare tablets appeared on sale on a Chinese language language web site and likewise a Chinese language social media app, in line with a Reuters evaluate. Gross sales of semaglutide by a Chinese language firm may quantity to an infringement of Novo Nordisk’s China patent, mentioned Frank Yang, senior affiliate at Marks & Clerk Mental Property Company in reply to a Reuters question about doable licences breaches.
A spokeswoman for Novo Nordisk mentioned the corporate doesn’t produce the ingredient in China.
The China Nationwide Mental Property Administration declared the Danish drugmaker’s patent invalid in September 2022. Nonetheless, Novo Nordisk efficiently appealed this determination.
Novo Nordisk informed Reuters it’s now awaiting a courtroom determination on a subsequent enchantment.
“We hope to see a continued development in supporting and defending innovation throughout patent invalidation proceedings,” a Novo Nordisk spokesperson mentioned in response to questions on whether or not it was implementing its patent in China.
Contacted by Reuters by fax, the Chinese language medication regulator didn’t reply to queries about quality control on the Chinese language companies making semaglutide.
A second Chinese language agency, Shanghai Longtide Biotechnology, which described itself as a biotechnology firm, additionally displayed a field of Semagcare tablets at its sales space at a separate commerce present in Shenzhen that Reuters additionally attended. Reuters contacted Boten Elemento Pharma by its web site however the firm didn’t reply. A enterprise registered as Shanghai Longtide Biotechnology didn’t reply to requests for remark.
BENDING BOUNDARIES A 3rd Chinese language biotechnology agency, Zhejiang Peptites Biotech, is among the many suppliers of semaglutide to Incepta, the information from the industrial customs information supplier confirmed. The Bangladeshi drugmaker has imported no less than 892 grams of semaglutide valued at about $805,000 between 2020 and 2024 from mainland China and Hong Kong, in line with a Reuters calculation based mostly on the customs information supplier’s cargo information for Zhejiang Peptites Biotech and different suppliers. Zhejiang Peptites Biotech additionally provided no less than 25.6 kg of semaglutide, valued about $2.8 million, to Russian drugmaker Geropharm in 2023 and 2024, in line with Reuters calculations based mostly on the customs information supplier’s information.
Geropharm can use innovations protected by Russian patents to offer semaglutide-based medicine to the native inhabitants with out Novo’s consent till the tip of December, in line with a Russian authorities decree issued in December 2023.
The Russian firm mentioned Zhejiang Peptites Biotech’s provide of semaglutide is carried out in accordance with a contract and it doesn’t export the completed drug, Semavic, overseas.
Nonetheless, Semavic was exported from Russia a number of instances to the breakaway Georgian area of Abkhazia, data from the industrial customs information supplier reviewed by Reuters confirmed.
Zhejiang Peptites Biotech didn’t reply to a request for touch upon shipments of semaglutide to Incepta and Geropharm.
The customs information confirmed that it was not solely Chinese language companies supplying semaglutide: Incepta has imported the ingredient from Swiss generic drugmaker Bachem. A spokesperson for Bachem mentioned it produces semaglutide for pharmaceutical firms for analysis and improvement functions solely and declined to touch upon its relationship with Incepta. Medicines regulator Swissmedic informed Reuters Bachem was authorised to export semaglutide, however added Swissmedic was “not supervising patents”.
