Some Chinese companies are now rushing to make generic versions of Wegovy de Novo Nordisk have also provided ingredients for more than a billion makeshift doses of weight loss drugs sold online in the United States in the last two years, according to three sources and a Reuters of shipping and public files.
The cheap copies of Wegovy and Zepbound of Eli Lilly are in retirement in the United States, because regulators restrict their sale, slowing down the expeditions of Chinese suppliers of raw ingredients which allowed explosive growth of drugs.
Robert Califf, who had two stays at the head of the Food and Drug Administration of the United States, said that a new medication had never become so popular before that the manufacturer could simply not follow.
The shortage opened the door for composition pharmacies, turbocharged by TV companies that prospered during the cocovated pandemic, to provide cheap copies to a huge market to continue the promised weight loss.
The pivot of generics approved by the FDA while patents expire in various countries follows a year of demand for brand drugs, which proved to be helping people eliminate up to 20% of their weight.
At least eight Chinese companies, including Jiangsu Sinopep-Alsino Biopharmaceutical and Hybio Pharmaceutical have helped the United States flooding the United States with crude semaglutide and shooting, the main ingredients of Wegovy and Zepbound have told Reuters. A reuters analysis of the delivery records of the American FDA supports this.
Habio and Sinopep work to launch their own generic semaglutides, according to one of the sources knowing the efforts and previous relationships of Reuters. The source also said that Nanjing Hanxin Pharmaceutical and Fujian Genohope Biotech, two of the companies that had provided compounds, could also be launched.
None of the companies responded to requests for comments.
American law now restricts pharmacies aggravating the production of personalized doses for patients who need it, or formulations not offered by brand medicines.
The source knowing the efforts of Hybio and Sinopep said that for a Chinese manufacturer, providing ingredients for compound weight loss drugs had been its biggest company. The manufacturer is now targeting markets where the main semaglutide patent in Novo expires next year, such as Canada and Brazil, to sell the ingredient to generic drug manufacturers, he said.
He said that he knew at least five other Chinese companies known to provide composition pharmacies that were also refocusing on the supply of semaglutide for generics.
It is unlikely that the switch will produce similar explosive growth. The manufacture of semaglutide in its final, injectable form is complex, said a lawyer for a manufacturer of generic drugs who asked for anonymity because he was not allowed to discuss the subject.
Companies that seek to sell generics can also conclude agreements with brand companies that delay their entry into the market.
“Problem once in a decade”
The composition of weight loss drugs in demand while brand drugs were rare represented an unprecedented opportunity.
In 2024 alone, the eight Chinese companies have sent enough raw materials to the United States to produce more than a billion starting doses of successful medicines, according to FDA shipping data.
Novo’s estimate is even higher. He said Chinese companies have sent enough semaglutide to the United States in just over six months to make start-up doses of 1.5 billion Wegovy, according to a letter submitted to the American trade department and published publicly.
In the first quarter of this year, the company’s supply shortages were no longer a problem and the pressing FDA for the end of the mass composition, Habio, Sinopep and others always brought significant ingredients to copy the two drugs.
In the second quarter, expeditions had plunged 90% compared to the previous year for the semaglutide, also the main ingredient of the novo diabetes of diabetes, and 34% for the shooting used to make Zepbound and Mounjaro copies.
The economy of Chinese companies selling from semaglutide to compounds was attractive. The offer of a month of semaglutide powder costs only 7 hundred to produce, according to a 2024 report in Jama. Chinese ingredient manufacturers can sell this for seven times more than seven times that manufacturers are looking to make copies, depending on the sales figures provided by the source.
American composition pharmacies sold injectable drugs for an average of $ 230 per month, more than half of brand prices.
The cost for Novo has been high. He missed quarterly sales targets and the actions of the Danish drug manufacturer were halved this year, contributing to the eviction of the CEO.
The files show that Sinopep, Habio and another company began to ship to the United States. More Liraglutide, the main ingredient of an older Novo drug sold under the brand names Victoza and Saxenda which cause more modest weight loss.
The generic versions of Liraglutide, available in the United States since 2024, are now presented by online remote charter sites that have once pushed the semaglutide.
A second source, a wholesaler who sells ingredients of obesity medication to worsen pharmacies but who was not authorized to speak publicly, said that he had seen an increase in sales of Liraglutides.
Marta Wosinska, a main person at the Brookings Institution who followed the rise of this industry, said that the Chinese manufacturing semaglutide expeditions exploded shortly after the FDA announced the shortage in 2022.
Califf said he expects companies to test the law restricting sales and that the FDA will set the tone for the application of industry councils. The FDA said that it was determined to use all the tools available to supervise the safety and quality of the FDA regulated products.
However, Califf said, the composition of weight loss drugs on a huge scale is probably a “problem once in a decade”.
