FDA approves Sanofi’s Humalog follow-on Admelog

The Food and Drug Administration has given full approval to Sanofi’s Admelog short-acting insulin lispro — a follow-on of Eli Lilly’s Humalog. The product received tentative approval from the FDA earlier this year, and now it is the first short-acting follow-on product to get the FDA’s stamp of approval.

“One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives,” FDA commissioner Scott Gottlieb said. “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. 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.”

Admelog was approved under the FDA’s abbreviated approval pathway, in which a manufacturer submits an application that relies partly on the FDA’s finding of safety and efficacy of a reference drug — in this case, Humalog — to support its approval. The product is typically administered before a meal to help manage blood sugar levels after eating in patients with Type 1 diabetes — who typically also require a long-acting insulin, including insulin glargine, insulin degludec or insulin detemir, the FDA said.

"Sanofi has a deep heritage and broad experience in providing treatments for people living with diabetes,” Sanofi executive vice president and head of global diabetes and cardiovascular Stefan Oelrich said. “Complementing our existing insulin portfolio, Admelog will offer a more affordable option for those who require control of their blood sugar levels at mealtime. The approval of Admelog is an important milestone for Sanofi in our mission to serve patients living with chronic diseases such as diabetes.”

Sanofi said Admelog would be available in vials and the SoloStar pre-filled pen, which it said is the United States’ most-used disposable insulin pen platform. The FDA approval follows Admelog’s approval by the European Commission in July 2017 as a biosimilar.