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The U.S. Food and Drug Administration on Monday approved A generic version of the daily injectable GLP-1 drug liraglutide for patients with type 2 diabetes, opening the door to lower-cost options to enter the market and address the shortage.
Liraglutide, sold under the trade name victoza It is an early product in the same class as semaglutide, an active ingredient for diabetes. Ozempic. Both are sold by Danish pharmaceutical giant Novo Nordisk.
Generic liraglutide is sold by Hikma Pharmaceuticals USA, and a spokesperson told CNN in an email that the company plans to make the drug available nationwide by the end of the year. The company did not disclose the expected price of the generic drug, saying only that it “will be priced lower than branded Victoza.”
Branded drugs cost between $500 and $815 per package, depending on dosage, before discounts and insurance. According to Novo Nordisk also sells a version of liraglutide, which is approved as an obesity treatment. saxenda.
“There are a lot of people taking this drug who would benefit from another generic version.” Dr. Harlan Krumholzcardiologists at Yale University and Yale New Haven Hospital told CNN via email.
However, Krumholz noted that newer GLP-1 drugs, which are given as injections once a week rather than daily, have shown stronger effects, especially for obese patients, and they are not yet available as generic drugs. .
These include Ozempic and its sister drug, Wigovy, which uses semaglutide, which is approved as an obesity drug, and Munjaro and Zepbound, diabetes and obesity drugs, respectively, which use the active ingredient tirzepatide. Without insurance or discounts, it can cost more than $1,000 per month.
“This could create a two-tiered system in which people who cannot afford more expensive drugs only have access to drugs for which the evidence of efficacy is not as strong,” Krumholz said.
Another generic drug maker, Teva Pharmaceuticals, authorized generic A version of liraglutide was announced in the United States in June. settlement agreement Approved generic medicines are manufactured by Novo Nordisk and distributed and sold by Teva. The price was not immediately available.
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Authorized generics are different from generic drugs, so According to This is because the brand name is not written on the label, but the drug is “exactly the same drug” as the branded drug. Like the generic version of liraglutide approved on Monday, generic drugs are copies of branded drugs developed and manufactured by other companies.
“Generic drugs generally provide additional treatment options that are more affordable for patients. Today’s approval continues FDA’s commitment to facilitating patient access to safe, effective, and high-quality generic drug products. “This is a testament to the ongoing efforts of the FDA,” said Dr. Eiln Murphy, director of the Generic Drugs Division in the FDA’s Center for Drug Evaluation and Research. statement.
Generic drugs also differ from compound drugs, which are manufactured in pharmacies and are allowed in case of drug shortages. Although the tirzepatide shortage had just been declared over, the lack of these drugs in recent years has flooded the market, especially combinations of semaglutide and tirzepatide. The agency warns that compounded products are not as tightly regulated as generic or branded drugs.
Contains liraglutide shortage It has been on sale in the U.S. since July 2023, according to the FDA’s database. “We are prioritizing the evaluation of generic drug applications for medicines in short supply to improve patient access to medicines,” the agency said in a statement Monday.
