Appropriate studies have not been performed on the relationship of age to the effects of Wegovy® in children younger than 12 years of age for weight management and lowering the risk of heart attack or stroke and in children to treat MASH. As semaglutide is not yet approved for use in China, it is not legally available for purchase within the country. Patients should not attempt to import or purchase semaglutide from unauthorized sources, as this may result in legal consequences or potential health risks from counterfeit or contaminated products. Approved for sale in China in 2021, Novo saw the diabetes drug Ozempic sales in the country nearly double over the last few years, topping out at nearly $700 million.
- These six shipments accounted for 221kg out of the 268kg reported metric volume during the March 2023 to September 2024 timeframe.
- Slowing gastric emptying causes nutrients to be absorbed more slowly, reducing the rate and magnitude of blood sugar rises.
- The recent approval of Wegovy, a semaglutide formulation designed for weight management, highlights the urgent need for accessible therapeutics.
- FDA could also be requesting COAs from manufacturers, along with samples of product, and then testing them for potential impurities, informed by engagement on CMC sections for already submitted ANDAs.
- Once a doctor prescribes the medication, a person can pick up Wegovy at their local pharmacy on the same day.
Successfully overcoming these challenges while addressing market needs is necessary for success in this rapidly changing sector. Insulin resistance represents a significant health challenge, often leading to type 2 diabetes and obesity. The rise of semaglutide biosimilars presents promising solutions, especially in the dynamic Chinese market. With Novo Nordisk’s Ozempic nearing patent expiration in 2026, Chinese pharmaceutical companies are developing rapidly biosimilars like Jiyoutai, offering cost-effective alternatives. These medications mimic semaglutide’s effects, improving insulin sensitivity and promoting weight loss—necessary factors in managing obesity-related insulin resistance. The rise of semaglutide biosimilars in China is a pivotal response to the escalating obesity crisis and its critical implications for diabetes management.
Insurance coverage
Among the resulting 11 firms, one European and one Chinese are likely part of submitted ANDA applications, based on the timing of their DMFs and the payment of GDUFA DMF user fees. One firm whose shipments were rejected was a DMF holder without an NDC code. Figure 1 plots the number of semaglutide manufacturers requesting NDC codes for semaglutide powder, all organized by the date of the first NDC request. Additionally, manufacturers that obtained NDC codes are organized by country.
This burgeoning competitive place fosters innovation and promises more affordable treatment options for patients. The emergence of GLP-1 receptor agonists, particularly semaglutide, marks a pivotal shift in obesity management. As Mainland China faces a pressing obesity crisis, the introduction of semaglutide biosimilars is critical. These medications mimic natural hormones, boosting insulin secretion and suppressing appetite, which promotes effective weight loss. This means that drugmakers “need to swallow hefty price cuts” to get their products listed on China’s list of drugs that are covered by state-funded medical insurance, Business Insider reported.
This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, including feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away. In China, where 148 million patients live with diabetes and the number of overweight or obese individuals is projected to hit 610 million by 2030, demand is exploding. Analysts forecast the Chinese semaglutide market will climb from $3.5 billion in 2022 to $61 billion by 2032.
China’s ‘growing enthusiasm’ for GLP-1s
Another issue is that the repeated coupling and washing steps may result in final product impurities if not properly conducted. Testing of compounded products has found formaldehyde and various unidentified impurities. It increases the production of insulin by mimicking the action of the incretin GLP-1. It appears to enhance the growth of pancreatic beta cells, which are responsible for the production and release of insulin. It is a medicine that is ordinarily used to treat a condition known as type 2 diabetes. It belongs to a class of medications called glucagon-like peptide-1 receptor agonists (GLP-1 agonists).
Compounding pharmacies serve an important role in the US health care system, offering, for example, ways for patients with allergies to get custom-mixed versions of lifesaving drugs. Advocates of compounding stress that the practice has been around for a long time and that the FDA permits it to preserve vital access to medication. “Media reports describe it as a loophole,” says Alliance for Pharmacy Compounding CEO Scott Brunner. With a potential customer base of most people—and that’s in the US alone—at least one industry analyst projects annual sales of GLP-1s could be up to $100 billion within the next decade.
Novo Nordisk braces for generic challenge to Ozempic, Wegovy in China
In June 2023, the FDA signed off on the use of semaglutide for chronic weight management, for which it carries the brand name Wegovy. For chronic weight management, Wegovy is usually prescribed as a monotherapy (used alone) and not in combination with other weight-loss medications. In any case, it tends to be utilized close by way of life changes, for example, ordinary activity and a decreased calorie diet to boost its viability. It is accessible as an injectable prescription and is commonly utilized close by diet and exercise to assist improve glycemic control in people with type 2 diabetes. Similarly as with any medicine, it is critical to talk with a medical services proficient for customized counsel and direction in regards to its utilization.
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.
A comparison of legal filings and the list of DMF holders suggests that some Indian manufacturers are indeed developing generic semaglutide in-house. Pharmacopeia (USP) monographs, which lay out expectations around the drug’s identity, strength, and purity, including relevant tests. Monographs are developed through an extensive scientific process, usually finalized around the time generics enter the market. If no USP monograph exists—as is in the case of semaglutide—FDA does not require the development of a new monograph for approval, but applicants should work with USP to create a monograph through the USP buy semaglutide india Pending Monograph Process (USP-PMP). Once a doctor prescribes the medication, a person can pick up Wegovy at their local pharmacy on the same day.
Safety and Side Effects
Decreasing hunger, boosting feelings of fullness, and delaying stomach emptying may aid in weight loss. According to studies, people who took it saw more significant weight loss than those who took a placebo. It helps the pancreas release the correct amount of insulin in the body when blood sugar levels are high. Once people decide to use it, they can be sure that they can now cope with type 2 diabetes and any other complications such as numbness, cold legs, decreased sexual performance, vision loss, and gum disease that may result from the condition. At least 15 generic versions of Novo Nordisk’s top-selling weight-loss and diabetes drug semaglutide are being developed in China, potentially threatening the Danish pharma’s dominance in one of its major target markets, according to Reuters.
However, with semaglutide still under patent protection, there is no USP monograph spelling out specifications for a quality product. Unless the bulk manufacturer was referenced in one of the ANDAs filed in December 2021 or later, there would have been no engagement with either USP or FDA on appropriate product specifications. In other words, many, if not most, semaglutide bulk manufacturers shipping semaglutide to the U.S. are defining for themselves what constitutes a quality product—a problem for a complex active ingredient. Not every one of the firms described above is necessarily shipping product to the U.S.
American patients deserve to have their drugs be safe and effective—whether they are approved or not. Right now, that is far from guaranteed, with patients having no visibility as to who is making their products and whether they are using reasonable standards to assure the quality of their products. Many people are wondering how to get Wegovy as the drug increases in popularity and availability. Several online services, including PlushCare and Sesame Care, offer prescriptions for this medication. It is important to vet each online pharmacy carefully to ensure it offers a safe version of this drug.
