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FDA approves first short-acting, follow-on biologic of Lilly's Humalog insulin product

Published on 12/12/17 at 10:21am

The FDA has announced its approval of Sanofi’s Admelog (insulin lispro), the first follow-on biologic version of Eli Lilly’s Humalog – a short-acting insulin authorised for the improvement of glycaemic control in in adults and children aged three years and older with type 1 diabetes and adults with type 2 diabetes.

The data which prompted the decision was derived from two Phase 3 trials comprising around 1,000 patients, but also relied on FDA findings regarding safety and efficacy of the drug’s originator prouct, Humalog.

Diabetes affects over 30 million US citizens, according to data from the Centers for Disease Control and Prevention. The approval decision follows the FDA’s current push to bring down drug costs by facilitating greater competition in the market, as directed by Commissioner Scott Gottlieb who stepped into the top role earlier this year.

“One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives. This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient's lifetime to manage a chronic disease,” noted Gottlieb. “In the coming months, we'll be taking additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe and effective alternatives to brand name drugs approved through the agency's abbreviated pathways.”

Sanofi Vice President Stefan Oelrich added: “Complementing our existing insulin portfolio, Admelog will offer a more affordable option for those who require control of their blood sugar levels at mealtime.”  

Matt Fellows

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