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New insulin glargine awarded tentative FDA approval
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The FDA has granted tentative approval for a new insulin glargine injection developed by Eli Lilly and Company and Boehringer Ingelheim to improve blood glucose control in patients with diabetes, according to a statement from the manufacturing alliance.
Basaglar, a basal insulin intended to provide long-lasting glycemic control between meals and during the night, is indicated to benefit adults with type 2 diabetes in conjunction with mealtime insulin and children with type 1 diabetes.
“We are confident that Basaglar, upon final approval, will become a valuable treatment choice for people who need a basal insulin to manage their type 1 or type 2 diabetes,” said Christopher Arbet-Engels, MD, PhD, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc., said in the statement.
Although the therapy meets regulatory requirements, the tentative approval comes based on an automatic stay of litigation by Sanofi claiming patent infringement, according to the statement. Unless the court finds in favor of Lilly early, the FDA cannot give final approval until after 30 months, or mid-2016.
Created with the same amino acid sequence as the currently marketed insulin glargine (Lantus, Sanofi Aventis), Basaglar was tentatively approved for use with the pre-filled dosing device KwikPen. The new drug application was filed through an FDA regulatory pathway that allows the agency to consider the efficacy and safety of the existing insulin glargine product.
Lilly-Boehringer Ingelheim’s insulin glargine product is considered a biosimilar in other regions such as Europe, where the drug is approved under the name Abasria. However, the new therapy is not considered a biosimilar in the United States.
Perspective
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Athena Philis-Tsimikas, MD
The general perspective of basal insulins is they are very valuable — especially the analogs, because they provide a more consistent release of insulin over a 24-hour time period.
The analogs glargine (Lantus, Sanofi Aventis) and Levemir (insulin detemir, Novo Nordisk), both available today in the United States, have the market share but can be limited for those patients who don’t have insurance and are very expensive. A potential value of having an additional biosimilar on the market is that it could provide competition and maybe lower the price; that’s a potential value.
We do have to be careful, however, because producing analog insulin is a very specific process, which has to be done in a laboratory environment to ensure quality and consistency. From a physician and safety standpoint, there needs to be assurance that new products meet the same quality and consistency in delivery as the available basal insulin.
Safety and efficacy need to be assured for action, the length of time of action and any antibody production. This is a biologic product that is injected. The human body can produce antibodies against it. If antibodies are being produced, we want to know the efficacy remains the same.
The delivery is another critical piece, from a clinician standpoint. We have moved away from syringes and vials and toward pens; every company has a different approach to a pen — some have done it very well and others have had a hard time doing it. When patients take it home and actually have to deliver with a pen, it has to be a device that is easy to use and error-free.
Some other agents quickly coming down the pipeline behind Basaglar might make it even more convenient for patients. U200 and U300 are more concentrated insulins; in our population with obesity, we’re beginning to need those concentrated insulins and Basaglar doesn’t address that.
Degludec [KA1] [M(T2] from Novo and PEGylated (insulin lispro) from Lilly, both with submissions that are fairly close and probably coming out in the next couple years, are even longer-acting, more consistent insulins that may be useful in the same population.
The recently-approved inhaled insulin Afrezza (Mannkind) — a bolus insulin, not a basal — is one more thing on the market for practitioners to consider. Potentially, patients could use a biosimilar glargine with this inhaled insulin, the biosimilar becomes the basal and the inhaled becomes the short-acting bolus.
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