FDA approves Basaglar (insulin glargine injection) for type 1 & 2 diabetes- Eli Lilly / Boehringer

Eli Lilly and Boehringer have announced that the FDA granted approval for Basaglar (insulin glargine injection) 100 units/mL. Basaglar is a long-acting insulin with an identical amino acid sequence to Lantus, another U-100 insulin glargine. It is delivered via the prefilled Basaglar KwikPen.

The Basaglar FDA approval is based, in part, upon an extensive clinical development program. The submission included results from pharmacokinetic and pharmacodynamic studies, as well as Phase III studies in people with type 1 and type 2 diabetes comparing the safety and efficacy of Basaglar to US- and non-US-approved Lantus. The FDA approval follows Basaglar's tentative U.S. approval in August 2014, which was contingent upon patent litigation resolution which has now been settled with Lilly committed to pay royalties to Sanofi. Basaglar will be available in the US starting on December 15, 2016.

Comment: Basaglar is a follow on from Lantus and is FDA approved for adults and pediatrics in Type 1 Diabetes and for adults only in Type 2 Diabetes. This approval is on contrast to the EU and UK where the approval is in all cases of diabetes extended to children. The drug is treated as a biosimilar in Europe but not in the US where its registration was via the s.505(b)(2) pathway (which allows an application to rely on safety and efficacy data from another innovators product) and not via the new s. 351(k) pathway created under the Biologics Price Competition and Innovation Act.