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Drug Information Update- Basaglar (insulin glargine)

New Drug Approval - Basaglar (insulin glargine)

FDA Approval:

In December 2015, the FDA approved Basaglar (insulin glargine), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. 

Basaglar will compete with other long-acting insulin products, e.g. insulin glargine (Lantus, Toujeo), insulin detemir (Levemir), and insulin degludec (Tresiba). Basaglar was approved under an abbreviated approval pathway known as the 505(b)(2) pathway. The 505(b)(2) application required data demonstrating that Basaglar was sufficiently similar to Lantus in addition to data regarding the safety and efficacy of Basaglar in two clinical studies. This led to the approval of Basaglar as a “follow-on” biologic product. Basaglar is not considered a generic or a biosimilar to Lantus and is therefore not considered interchangeable at point of sale. 

Availability:

Basaglar is on the drug file this week. However, the manufacturer has noted that it will not go into production and will not be commercially available in pharmacies until Thursday, December 15th, 2016.

Drug File:

Basaglar is priced 15% AWP lower than Lantus. Basaglar shares the same GCN as Lantus but is a single source brand, not a generic or biosimilar to Lantus.  Basaglar is administered subcutaneously once daily.  Dosing of Basaglar should be individualized based on the patient’s needs. Basaglar has been launched with the following strength and dosage forms:

MedImpact Formulary & Utilization Management Strategies:

A full clinical review of Basaglar was conducted during the MedImpact 1st Quarter 2016 Pharmacy & Therapeutics (P&T) Committee Meeting on February 5th, 2016. During this review, the Committee approved utilization management (UM) strategies for Basaglar.

References:

Please see the following resources for more information:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm477734.htm

http://pi.lilly.com/us/basaglar-uspi.pdf

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