FDA Approves Sanofi’s Follow-On Insulin
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.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
