Approvals for biosimilar, CGM software
The FDA approved a biosimilar insulin and expanded its approval of an interoperable automated glycemic controller for use with continuous glucose monitors (CGMs) in recent weeks.
On Feb. 14, the FDA approved insulin-aspart-szjj (Merilog), a biosimilar to insulin aspart (Novolog), for the improvement of glycemic control in adults and pediatric patients with diabetes. It is the first rapid-acting insulin biosimilar product to gain approval and will be available in both a 3-ml single-use prefilled pen and a 10-ml multiple-dose vial.
On Feb. 24, the agency expanded approval of Tandem Diabetes Care, Inc.'s, control-IQ+ technology, an interoperable automated glycemic controller that is a software-only, prescription-use device. The device is intended for use with compatible integrated continuous glucose monitors and alternate controller-enabled pumps to automatically increase, decrease, and suspend delivery of basal insulin. This clearance allows the device to be used for the management of type 1 diabetes in individuals ages two years and older and for the management of type 2 diabetes in individuals 18 years and older, where the prior version was only approved for type 1 diabetes.