The Hyper-Competitive Rush for Semaglutide Biosimilars in China

Unlike online providers who don’t get to know you (and your medical records) in person, your primary care provider can monitor other health issues that might complicate things. When it comes to online compounding pharmacies, the National Association of Boards of Pharmacy, which represents the state regulators, has found more than 40,000 online pharmacies operating illegally or in a way they don’t recommend. Jennie Smith, a seamstress at a ballet school in Kent, Ohio, had been trying to lose weight and keep it off for years. After losing 60 pounds through dieting only to gain 30 of it back, she wanted to try the new weight-loss drugs like Wegovy. Meanwhile, clinical trial records show around 15 generic versions of Ozempic and Wegovy are currently being developed in China, Reuters reported last month.

When it is taken, it binds to GLP-1 receptors on various cells in the body. This binding activates the receptors and triggers physiological responses that help control blood sugar levels.As a GLP-1 receptor agonist, it mimics the effects of GLP-1. Ozempic stimulates insulin release from pancreatic beta cells in a glucose-dependent manner by binding and activating GLP-1 receptors.

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An adverse court ruling could make it lose its semaglutide exclusivity even sooner and turn China into the first major market where Novo is stripped of patent protection for the drugs. The Danish drugmaker has high hopes that demand for its blockbuster drugs will surge in China, which is estimated to have the world’s highest number of people who are overweight or obese. Dr. Usman (BSc, MBBS, MaRCP) completed his studies in medicine at the Royal College of Physicians, London. He is an avid researcher with more than 30 publications in internationally recognized peer-reviewed journals. Dr. Usman has worked as a researcher and a medical consultant for reputable pharmaceutical companies such as Johnson & Johnson and Sanofi.

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But compounding pharmacies counter that Novo Nordisk’s patents apply to finished medicines like Ozempic, not to the chemical that makes up semaglutide. They argue that the shortage of Ozempic and Wegovy gives them the right to make and market compounded equivalents. Qijian-bio is a premier leather products export company, established in 2010 and based in China. With a decade of experience, qijian-bio has built a reputation for delivering high-quality leather goods to clients across the globe. The company specializes in a wide range of leather products, including bags, wallets, belts, and custom leather accessories, all crafted with precision and attention to detail. Leveraging advanced manufacturing techniques and stringent quality control processes, qijian-bio ensures that each product meets the highest standards.

However, low blood sugar can occur when you use semaglutide with other medicines, including insulin or sulfonylureas, that can lower blood sugar. Low blood sugar also can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Large-scale clinical trials like the SUSTAIN, PIONEER, and SELECT investigations are among these trials. semaglutide austin tx where to buy Several clinical trials are being conducted for SUSTAIN’s research project to examine its therapeutic impact on type 2 diabetic patients. The trial’s results showed that people on it experienced reduced cardiovascular events and total mortality.

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These medicines work by helping the body to produce the right amount of insulin at the right time, which helps to regulate blood sugar. The introduction of semaglutide biosimilars in China marks a pivotal change in healthcare. As patents expire, innovative companies are launching cost-effective alternatives, remarkably improving patient access to necessary diabetes and weight loss treatments. This influx of competition is set to create a dynamic marketplace focused on addressing the needs of individuals facing obesity and related health issues.

• You can also ask the compounding pharmacist where they get their semaglutide, and check this FDA database online to see if that factory is registered with the FDA.
• Eight companies — Hangzhou Jiuyuan, Livzon, Qilu, Lianbang, Huadong Medicine, CSPC, Huisheng Biopharma and Chengdu Brilliant Pharma— have filed marketing applications, mostly for type 2 diabetes.
• The drug won U.S. approval in December 2017 for type 2 diabetes as Ozempic, which was subsequently approved in China in 2021.
• GLP-1 (Glucagon like peptide 1) receptor agonists, a commonly prescribed drug class in the treatment of type 2 diabetes (T2D), successfully mimic a natural gut hormone, increasing production of insulin in the human body.
• As Novo Nordisk’s flagship drug, Ozempic, nears its patent expiration in 2026, numerous Chinese companies are ready to introduce their own formulations.
• He is an avid researcher with more than 30 publications in internationally recognized peer-reviewed journals.

As the approval process accelerates, these state-of-the-art biosimilars are poised to improve accessibility and lower costs, in the end benefiting patients. The rapid approval of Wegovy, marketed as NovoCare in China, exemplifies this trend, with semaglutide becoming available for weight management just five months after regulatory clearance. Recent trends reveal a significant uptick in applications, with over 11 Chinese firms approaching the final stages of clinical trials for semaglutide generics. Remarkably, Jiuyuan Gene’s marketing application could lead to China’s initial biosimilar approval. This competitive environment not only addresses the growing obesity epidemic but also aims to provide affordable alternatives, as illustrated by Wegovy’s recent market introduction at approximately $193.27 per month.

For the indication of weight loss, no domestic semaglutide has been reported for production, but there are products under development that have entered Phase III clinical trials. The weight management indication of semaglutide applied for by Federal Biotech (Zhuhai Hengqin), a wholly-owned subsidiary of Federal Pharmaceutical, was approved for clinical trials in April 2023. 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.