Registered nurse Susan Eager (R) teaches a diabetic patient how to draw her own insulin injections during a house call on March 26, 2012 in Denver, Colorado.
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Eli Lilly and Company (LLY) and Boehringer Ingelheim Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration granted approval for Basaglar (insulin glargine injection) 100 units/mL.
It is considered as a biosimilar of Sanofi’s Lantus diabetes drug.
The FDA approved an insulin glargine injection (Basaglar) Wednesday, making use of an abbreviated approval pathway that has never been used for an insulin product.
The drug’s specific data included two clinical trials in which 534 and 744 patients having type 1 and 2 diabetes mellitus respectively.
About 29 million Americans and an estimated 415 million people globally have type 1 or type 2 diabetes. Over time, diabetes increases the risk of serious health complications, including heart disease, blindness, and nerve and kidney damage.
Basaglar should only be given according to the needs of the patient.
BASAGLAR is indicated to control high blood sugar in adults and children with type 1 diabetes and adults with type 2 diabetes. It is delivered via the prefilled BASAGLAR KwikPen.
The most common side effects for the drug include itching, rash, weight gain, fluid retention, allergic reaction, and hypoglycemia.
Severe, life-threatening, generalized allergic reactions, including anaphylaxis, or generalized skin reactions, angioedema, bronchospasm, hypotension and shock may occur with any insulin. FDA notes that the drug is not approved as a biosimilar; there are no insulin glargine products licensed under the Public Health Service Act, and thus there is no “reference product” for a proposed biosimilar.
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Now, thanks to a patent settlement signed in September, Lilly and Boehringer are preparing to launch their insulin in the US after Lantus’ market exclusivity expires on December 15, 2016.
