{"id":38547,"date":"2021-07-30T10:26:04","date_gmt":"2021-07-30T14:26:04","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=38547"},"modified":"2021-07-30T10:26:04","modified_gmt":"2021-07-30T14:26:04","slug":"semglee-insulin-biosimilars-fda-approval","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/semglee-insulin-biosimilars-fda-approval\/","title":{"rendered":"FDA approves first interchangeable biosimilar insulin product for diabetes treatment"},"content":{"rendered":"

On Jul. 28, 2021 the U.S. Food and Drug Administration (FDA)<\/span> approved<\/span><\/a> the first interchangeable biosimilar insulin product, <\/span>Semglee<\/span><\/a> (insulin glargine-yfgn) for treating <\/span>Type 1 and Type 2 diabetes<\/span><\/a>. Semglee is considered to be interchangeable with Sanofi\u2019s <\/span>Lantus<\/span><\/a>, the commonly prescribed brand name for insulin glargine.\u00a0<\/span><\/p>\n

Soon people who take Lantus to treat their diabetes can request the insulin alternative Semglee at the pharmacy without needing a change to their prescription in most states.<\/span><\/p>\n

\u201cThis is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,\u201d Acting FDA Commissioner Janet Woodcock, MD, said in an FDA press release.<\/span><\/p>\n

Typically, the list prices for biosimilar are about 15% to 35% lower than the products they reference, according to the FDA. That\u2019s critical considering that more than <\/span>34 million<\/span><\/a> Americans have diabetes and the price of insulin has increased dramatically. Between 2002 and 2013, for example, the list price for insulin<\/span> nearly tripled<\/span><\/a>.<\/span><\/p>\n

What are interchangeable biosimilar medications?<\/span><\/h2>\n

A biosimilar medication is one that the FDA considers to be highly similar, with no major clinical differences, to another biological product that they have already approved. These biosimilars also have been shown to be just as safe and effective as the referenced product. When the product is considered an interchangeable biosimilar product, that means it doesn\u2019t require a separate prescription to be used as a substitute.<\/span><\/p>\n

\u201cThe FDA\u2019s high standards for approval mean health care professionals and patients can be confident in the safety and effectiveness of an interchangeable biosimilar product, just as they would for the reference product,\u201d said Peter Stein, MD, director of the Office of New Drugs in the FDA\u2019s Center for Drug Evaluation and Research in an FDA press release.<\/span>\u00a0<\/span><\/p>\n

Although biosimilar products are often confused with generic versions of a medication, the two are not the same. <\/span>The biggest difference<\/span><\/a> is that biosimilar products are highly <\/span>similar<\/span><\/i> to another drug, whereas generic drugs must have the same active ingredient as the brand-name version of a drug.<\/span><\/p>\n

RELATED: <\/b>What is insulin?<\/b><\/a><\/p>\n

How does Semglee work?<\/span><\/h2>\n

Semglee, which was first approved by the FDA in June 2020, is part of a class of injectable, long-acting insulins sometimes called basal or background insulins. This type of insulin starts working about<\/span> two to four<\/span><\/a> hours after it is injected and is meant to keep the blood sugar of people with diabetes in a healthy range throughout the day.\u00a0<\/span><\/p>\n

What are the side effects of Semglee?<\/span><\/h2>\n

As with Lantus and other medications in the insulin glargine family, Semglee is not meant to be used when someone with diabetes is experiencing hypoglycemia (low blood sugar). According to the FDA, the most common side effects of Semglee include:<\/span><\/p>\n