Combination product: Insulin glargine pen injector

The pen injector is intended to deliver long-acting insulin used to tread adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for control of high blood sugar. The PMOA is assigned to the insulin glargine and most recently been filed with CDER following 505(b)(2) application. No insulin glargine products are currently licensed under the Public Health Service Act, so there is no “reference product” for a proposed biosimilar product.

Is Biosimilar Insulin Available?

https://www.basaglar.com/en/