In addition, it reduces food intake by reducing appetite and slowing digestion in the stomach, which ultimately reduces body fat and aids in weight loss. Basic information From a structural point of view, compared with liraglutide, the biggest change of semaglutide is that two AEEAs have been added to the side chain of lysine, and palmitic acid has been replaced by octadecanedioic acid. Alanine was replaced by Aib, which greatly extended the half-life of semaglutide. Novo’s semaglutide is a GLP-1 receptor agonist that works by mimicking the GLP-1 hormone and activating its corresponding receptor, inducing the release of insulin from the pancreas in response to blood sugar levels. The drug won U.S. approval in December 2017 for type 2 diabetes as Ozempic, which was subsequently approved in China in 2021.
It’s Shockingly Easy to Buy Off-Brand Ozempic Online, Even if You Don’t Need It
While some experts praise the policy to keep medicines affordable, drugmakers worry that slashed prices could hinder research and development costs. However, “the sheer size of China’s healthcare market” — the world’s second-largest — means that companies can recoup their research costs, one pharma marketing executive told Insider. This, in turn, created a legal pathway for pharmacy compounding of exact copies of the patent-protected, FDA-approved products. These compounded products are not made in drug manufacturing facilities but are mixed by pharmacies. Telehealth services offer several weight loss medications, including Wegovy.
Semaglutide 10mg: A Breakthrough in Weight Management and Diabetes Care
Cardiovascular (CV) outcome trials show it can reduce various CV risk factors in people with established CV disease. It is often given with other oral antidiabetic drugs (such as metformin, sulfonylureas, or thiazolidinediones) to enhance glycemic control further. As a GLP-1 (glucagon-like peptide 1) receptor agonist, semaglutide has emerged as a life-changing option for people who are overweight or obese. They are committed to losing significant weight and have no other underlying health conditions problem. It’s a long-acting prescription drug designed to prolong use for months or more.
2) Semaglutide lowers blood sugar by stimulating insulin secretion and reducing glucagon secretion. When blood sugar is high, insulin secretion is stimulated and glucagon secretion is inhibited. 3) Novo Nordisk PIONEER clinical trial showed that oral administration of semaglutide 1mg, 0.5mg has better hypoglycemic and weight loss effects than Trulicity (dulaglutide) 1.5mg, 0.75mg. Oral administration once a day can get rid of the inconvenience and psychological torture caused by injection, and it is better than liraglutide (injection once a week). The hypoglycemic and weight-loss effects of mainstream drugs such as , empagliflozin (SGLT-2) and sitagliptin (DPP-4) are very attractive to patients and doctors.
Regulatory barriers frequently delay approval processes, obstructing the introduction of affordable alternatives. As Novo Nordisk’s Ozempic patent approaches expiration in 2026, competition intensifies among at least 11 Chinese firms, including Huadong Medicine and Livzon New North River, all excited to penetrate the market. After the official market entry of “Semaglutide for weight loss” (Novo Nordisk’s Wegovy®) in November, another important member of the semaglutide family—oral semaglutide , Rybelsus®—is set to take center stage in clinical practice.
When Jennie Smith told her primary care doctor about using compounded semaglutide purchased online, he scolded her that she should try to lose the weight on her own. Compounding pharmacists are not supposed to make what are “essentially” copies of commercially available approved drugs, according to the FDA. But sometimes, compounding pharmacies can legally pitch in during a drug shortage. Meanwhile, clinical trial records show around 15 generic versions of Ozempic and Wegovy are currently being developed in China, Reuters reported last month. Ozempic was approved in China as an injection in August 2021 and as an oral tablet in January to be used by Type-2 diabetics.
Novo Nordisk’s Wegovy weight loss drug approved in China
So Smith did some research and found a cheaper version on one of dozens of online pharmacies that tout their own copies of these weight-loss drugs. The approval comes as the patent on the drug’s active ingredient, Semaglutide, is set to expire in China in 2026 and as competition heats up from domestic drug makers in the market. Novo Nordisk did not immediately respond to CNBC’s request for further information on the proposed pricing and rollout timeline of the drugs. The Danish pharmaceutical giant said in March it would initially focus on patients paying out-of-pocket, Reuters reported. If the generic versions are proven to be as safe and effective as Ozempic, its price in China will likely drop by about 25 percent, according to a report by Goldman Sachs.
China’s Creating Cheapo Versions of Ozempic That Could Majorly Shake Up the Market
The data, including for Novo Nordisk’s Ozempic shipments, only goes back to March 2023, so I do not observe the initial semaglutide import activity. Table 1 summarizes the regulatory standards for semaglutide bulk used in compounding versus semaglutide API used in abbreviated new drug applications (ANDAs). I am using ANDAs as a reference because they are copies of the branded semaglutide products, just as compounded products are.
It is the first company in China to obtain clinical approval for the weight management indication of this biosimilar. And Hanyu Pharmaceutical’s semaglutide injection is the first similar drug in China to enter Phase III clinical trials for the indication of weight management. China approved the use of semaglutide for Type 2 diabetes patients in 2021, while the country’s drug evaluation department approved its clinical trials for treating chronic weight management in adults in September. Developed by a Danish pharmaceutical company and sold under the brand names Wegovy and Ozempic, the drug is only available through prescription, though its recent popularity has attracted scalpers facilitating an illicit market. As Novo Nordisk’s patent approaches expiration in 2026, the market for semaglutide biosimilars is rapidly changing. Currently, at least 11 Chinese companies are advancing through clinical trials, paving the way for the introduction of Wegovy and its biosimilars.
Any firms producing bulk product must also register with FDA in the so-called electronic Drug Registration & Listing System (eDRLS). Using eDRLS and the unfinished product NDC directory, one can determine who is marketing semaglutide bulk to U.S. buyers, when they began to do that, and where their business is located. The regulation and oversight of bulk manufacturing for compounding differs substantially from that of manufacturers supplying API for branded or generic products. To receive a prescription for Wegovy from PlushCare, a person must book an appointment with a board certified professional with experience treating weight management concerns. Noom is a company that aims to help people lose weight and maintain this weight loss healthily and sustainably. When signing up for Ro Body, individuals will have a consultation with one of Ro’s healthcare professional partners.
They work to prevent the sale and distribution of unauthorized and counterfeit medications, ensuring the safety and efficacy of treatments available to Chinese patients. The first GLP-1RA generic was approved in the US last week when the US Food and Drug Administration (FDA) greenlit Teva’s drug referencing Novo Nordisk’s Saxenda (liraglutide). However, Saxenda is not one of the new-generation weight loss drugs and is far less popular than semaglutide and Lilly’s tirzepatide. The emergence of biosimilars is revolutionizing diabetes treatment, particularly with the launch of semaglutide biosimilars in China. In response to a nationwide obesity epidemic, innovative biosimilars like Jiyoutai are entering the market to rival Novo Nordisk’s Ozempic, especially as its patent nears expiration in 2026. This competitive place is critical for lowering treatment costs and enhancing patient access.
- They work to prevent the sale and distribution of unauthorized and counterfeit medications, ensuring the safety and efficacy of treatments available to Chinese patients.
- It is often given with other oral antidiabetic drugs (such as metformin, sulfonylureas, or thiazolidinediones) to enhance glycemic control further.
- Rybelsus® contains a special excipient called sodium N-(8-2-hydroxybenzoylamino)caprylate (SNAC).
- PEG modification not only tightly binds to albumin, masking the DPP-4 enzyme hydrolysis site, but also reduces renal excretion, prolongs the biological half-life, and achieves the effect of long circulation.
So far in 2024, the company has witnessed a spike in the number of “violative or problematic” GLP-1 ads, including those making false claims about what the drugs can do and ads from unlicensed pharmacies. In the first half of 2024, LegitScript has seen twice as many violative or problematic ads as it saw in 2023. WIRED’s experience ordering these medications suggests that people who do not meet the criteria to get these drugs prescribed will not have a difficult time circumventing the guardrails in place. They did all send instructions for how to inject the medications safely, buy semaglutide cheap and the Henry practitioner who conferenced with me gave a very clear visual tutorial.