The safety issues of compound generic drugs of semaglutide preparations are attracting attention.
At the beginning of this month, the FDA (US Food and Drug Administration) warned that on August 14th of this year, a patient complained that black particles were found in a bottle of semaglutide formulation distributed at the Fullerton Wellness factory in California. Subsequently, defects were discovered in the factory during a state-level inspection. After this inspection, the factory voluntarily ceased operations. The FDA stated that this factory uses unsterilized raw materials to produce composite versions of weight loss drugs from companies such as Novo Nordisk and Eli Lilly, which may pose risks of infection and sepsis.
On Wednesday (November 6th) local time, Karsten Munk Knudsen, Chief Financial Officer of Novo Nordisk, stated that the company has learned that 10 users of compound generic weight loss drugs have died and another 100 have been hospitalized.
Novo Nordisk's semaglutide formulation has long been in short supply. In order to meet market demand, composite pharmaceutical companies and pharmacies replicate this drug by combining, mixing, or altering its ingredients.
The FDA warned of risks earlier this month
Novo Nordisk Chief Financial Officer Karsten Munk Knudsen announced on Wednesday (November 6th) that Novo Nordisk has learned that 10 people have died and another 100 have been hospitalized among those taking compound generic weight loss pills.
The weight-loss drug mentioned by Karsten Munk Knudsen is the smeglutide preparation produced by Novo Nordisk. At present, this preparation is approved for the treatment of type 2 diabetes and weight control for overweight or obese people. Due to the long-term supply shortage of the drug, semaglutide has been marked as a shortage by the FDA.
In order to meet market demand, composite pharmaceutical companies and pharmacies replicate this drug by combining, mixing, or altering its ingredients. According to US regulations, compound imitation products comply with relevant regulations. But Karsten Munk Knudsen said that Novo Nordisk has been researching some of the compound products on the market and has found that these products have many different types of safety issues, as well as reports of hospitalizations and deaths.
According to the FDA's adverse event database, there have been 10 deaths related to compound semaglutide in the past two years. However, it should be noted that FDA reports cannot prove that a potential hazardous health event was caused by a certain drug.
Previously, Novo Nordisk also requested that the FDA include semaglutide in the "List of Proving Difficulties in Synthesis". Novo Nordisk CEO Lars Fruergaard Jorgensen stated that injecting a product that is not regulated, approved, or inspected is puzzling. Zhou Fude mentioned that this generic drug is sold online and through some so-called "health projects", without a formal supply chain.
Just before Karsten Munk Knudsen's speech, the FDA also warned on the 1st of this month not to use compound drugs produced by a factory in California. This pharmaceutical factory called Fullerton Wellness produces composite versions of weight loss drugs from companies such as Novo Nordisk and Eli Lilly, and distributes these drugs to patients through medical clinics and clinics. According to the FDA, the Fullerton Wellness factory uses unsterilized raw materials to produce these injectable drugs without undergoing disinfection procedures, which may pose risks such as infection and sepsis.
The FDA stated that on August 14th of this year, a patient complained that black particles were found in a bottle of semaglutide formulation distributed at the Fullerton Wellness factory. Subsequently, defects were discovered in the factory during a state-level inspection. After this inspection, the factory voluntarily ceased operations.
There are also products sold domestically under the banner of "semaglutide"
The problem of compound preparations of semaglutide is not only present abroad.
In July of this year, the Daily Economic News published a report titled "GLP-1 is traffic, some people sell 'oral semaglutide', Novo Nordisk exclusively responds: no third party has been authorized to carry out such behavior". It is pointed out that there are many products on the market that use "oral semaglutide" and "oral GLP-1" as gimmicks, and even directly claim to have "technical cooperation with Novo Nordisk" for promotion and sales. Among them, there are also companies suspected of recruiting "partners" through pyramid schemes.
At that time, Novo Nordisk exclusively responded to a reporter from the Daily Economic News, saying, "Recently, our company has discovered that there are illegal elements suspected of producing and selling counterfeit products of our company for infringement and illegal criminal activities. Our company is actively cooperating with law enforcement agencies to crack down on related infringement and illegal criminal activities. Regarding the companies or brands claiming to have technical cooperation with Novo Nordisk, Novo Nordisk has stated that it has never collaborated, developed, produced, or sold such unapproved products with any third party in China, nor has it authorized any third party to use Novo Nordisk's brand or company name to carry out such activities. The relevant corporate actions are suspected of constituting infringement.
At that time, Fan Guorong, director of the Clinical Pharmacy Department at the First People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, told the Daily Economic News reporter that such suspected counterfeit and inferior products could not guarantee safety, had unknown ingredients, inaccurate dosages, and posed multiple risks such as unreliable treatment effects and health threats. Such products may not contain semaglutide at all. Even if they do contain semaglutide, they have not undergone scientific clinical trials, and the production and storage conditions may not comply with regulations. The therapeutic effect cannot be guaranteed, and the risk of adverse reactions in patients after using these products may also increase
The popularity of generic preparations of semaglutide is related to the long-term supply shortage of the drug.
According to the latest financial report released by Novo Nordisk, its third quarter revenue was 71.311 billion Danish kroner, a year-on-year increase of 22%, and its net profit was 27.301 billion Danish kroner, a year-on-year increase of 21%, higher than market expectations. Overall, in the first three quarters, Novo Nordisk's revenue was KRK 204.72 billion, a year-on-year increase of 23%, and its net profit was KRK 72.758 billion, a year-on-year increase of 18%. The growth of performance is mainly driven by the growth of GLP-1 in the treatment of diabetes and obesity.
In the first three quarters, Ozempic's revenue from the hypoglycemic version of semaglutide injection was 86.489 billion Danish kroner, a year-on-year increase of 32%; The revenue of Rybelsus oral version of semaglutide tablets was 16.384 billion Danish kroner, a year-on-year increase of 29%; Wegovy's revenue for the weight loss version of Simeglutide Injection was 38.34 billion Danish kroner, approximately 5.532 billion US dollars, a year-on-year increase of 77%. The three indications of semaglutide combined contributed a total of DKK 1412.13 billion, approximately USD 20.292 billion, to Novo Nordisk in the first three quarters, accounting for nearly 70% of Novo Nordisk's total revenue.
Faced with strong demand, Novo Nordisk has repeatedly announced plans to expand production capacity. In November 2023, Novo Nordisk will upgrade its local factory scale expansion plan in Denmark, with an expected total investment of over 6 billion US dollars. In June of this year, the company announced an investment of $4.1 billion to expand its manufacturing capacity in the United States. The plan is to build a second filling and finishing manufacturing plant in Clayton, North Carolina, USA.
Another diabetes and weight-loss drug Tilpoltide is also at risk of shortage. In May of this year, manufacturer Eli Lilly announced the largest production capacity investment in its 150 year history - an additional $5.3 billion, bringing the total investment to $9 billion for expanding production to increase the output of tilpotide. In fact, since 2020, Eli Lilly has announced investments of over $20 billion to expand production, including building and acquiring factories in the United States, Ireland, Germany, and other locations.