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FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

The Pharma Data

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.

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Top 15 Diabetes Drugs in 2023 by 2022 Sales Statistics

XTalks

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics.

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FDA Warns About Compounded Versions of Ozempic and Wegovy

XTalks

GLP-1 stimulates insulin production, thus reducing blood glucose levels, and it interacts with the brain to suppress appetite and create a feeling of fullness. As of May 2023, both Ozempic and Wegovy were on the FDA’s Drug Shortages list due to a global shortage of semaglutide. mg and 2.4 mg doses of Wegovy.

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The US biosimilar market: Predictions for 2021

pharmaphorum

One of these markets is the insulin market. Up until now, the insulin market has experienced little competition and, as a result, prices have soared over the years. Currently, more than seven million patients rely on insulin, and that number is growing each year. But, that will soon be changing, due to biosimilars.

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STAT+: Pharmalittle: WHO pandemic accord may force pharma to disclose prices; FDA OKs first therapy to delay type 1 diabetes

STAT News

Diabetic patients will now have easier access to insulin after the FDA approved an Eli Lilly biosimilar as interchangeable with the biologic drug , Bloomberg News notes. Rezvoglar,

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Five things to watch as the Biosimilars market heats up in 2022

pharmaphorum

And already in the first quarter of 2022, the FDA approved a third filgrastim biosimilar, Releuko. With 34 approved biosimilars and dozens more in the pipeline, what does this year have in store? In September of 2021, the FDA approved Byooviz , which references Roche and Novartis’ blockbuster eye drug Lucentis.

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STAT+: Pharmalittle: J&J drops out of bidding for Horizon; FDA takes a harder line on fast-track approvals

STAT News

Meantime, the FDA told ImmunoGen and ADC Therapeutics, which have been developing cancer drugs, that it would not grant a speedy approval until they had begun follow-up studies. Advocates and legal experts say the suit has no merit, but they fear conservative courts will think otherwise.

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