FDA Approves Sanofi’s Follow-On Insulin

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The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.

On Dec. 11, 2017, FDA approved Admelog (insulin lispro injection), a short-acting insulin manufactured by Sanofi that is indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with Type 1 diabetes mellitus and adults with Type 2 diabetes mellitus. Admelog is the first short-acting insulin approved as a “follow-on” product, according to the agency. The drug received tentative approval from FDA on Sep. 1, 2017 and is now being granted final approval.

Admelog is a rapid-acting insulin similar to Eli Lilly and Company’s Humalog, (insulin lispro 100 units/mL), which was approved by FDA in 1996. Lilly’s Humalog is one of the company’s top-selling drugs with 2016 sales of approximately $1.69 billion.

Admelog was approved by FDA through the 505(b)(2) pathway, an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act. It was previously granted marketing authorization as a biosimilar, under the proprietary name, Insulin lispro Sanofi, by the European Commission in July 2017.


Source: FDA and Sanofi