Tagged as: insulin

FDA Classifies Insulin as Biologic; Biosimilar Insulin Applications Accepted Beginning March 23, 2020

On February 21, the FDA published a final rule in the Federal Register that implemented a requirement of the BPCIA, transitioning insulin, and some other products such as human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropinalfa, and menotropins, from regulation as small molecule drugs to biologics.  With respect to insulin,…

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Insulin Biosimilars Update

Some noteworthy regulatory and litigation events related to insulin biosimilars have occurred recently. On May 13, 2019, FDA held a public hearing entitled “The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products” at FDA’s White Oak campus in Silver Spring, Maryland. …

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Lilly to Launch Lower-Priced Insulin Product

On March 4, 2019, Eli Lilly announced that they will begin selling a lower-priced version of Humalog® (isulin lispro injection 100 units/mL) in the United States with a list price 50% lower than the current Humalog® list price.  The lower-priced version will be called Insulin Lispro and will be provided in…

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