Sanofi wins US approval for ‘follow-on’ Humalog insulin copy

In July, Sanofi’s Admelog mealtime insulin was approved in Europe as a biosimilar to Eli Lilly’s insulin lispro Humalog. And this week the US Food and Drug Administration (FDA) has approved the product, but as a follow-on biologic, and not a biosimilar.

This was because Sanofi submitted Admelog to the FDA through the 505(b)(2) pathway, making it a and a follow-on product, spokesperson Anna Robinson said, and not through the dedicated biosimilar 351(k) pathway created by the Biologics Price Competition and Innovation Act in 2009.

“A 505(b)(2) application is an application for approval of different dosage forms, formulations, or combination products of already-approved drugs, but can also be available for approval of biologics that are similar to, and rely on information contained in, a previously-approved New Drug Application (NDA),”​ she told Biopharma-Reporter.

“​Since Humalog was approved as a drug through the NDA process, we were required to follow the same pathway with the 505(b)(2) submission.”​

Sanofi submitted the application for Admelog in November 2016.

The approval of Admelog was based on physicochemical, non-clinical and clinical similarity to Humalog 100 Units/mL currently, Robinson added, and included data from a clinical development program involving more than 1,000 adults living with type 1 or type 2 diabetes.

Robinson said Sanofi expects the product to be commercially available in the US early next year, but was unable to disclose Admelog manufacturing details.

Similar, but not biosimilar​

A follow-on product is neither a biosimilar nor a generic but a branded biopharmaceutical in its own right.

The pathway provides a shorter and less costly drug development programme for modified versions of a previously approved product and requires additional clinical and nonclinical studies - other than bioavailability (BA) or bioequivalence (BE) studies - to demonstrate safety and efficacy

Admelog’s approval mirrors Boehringer Ingelheim and Lilly’s Basaglar, approved via the 505(b)(2) pathway in 2015​ as a follow-on insulin glargine to Sanofi’s own Lantus.

Boehringer Ingelheim and Lilly’s product became the first insulin biosimilar to be approved in Europe in 2014​ under the brand name Abasria.