FDA clears Sanofi's Admelog as first follow-on biologic of Eli Lilly's Humalog to treat diabetes
Sanofi on Monday announced that the FDA approved Admelog (insulin lispro) as the first follow-on biologic version of Eli Lilly's Humalog. The therapy has been specifically authorised to improve glycaemic control in adults and children aged three years and older with type 1 diabetes and adults with type 2 diabetes. Sanofi vice president Stefan Oelrich remarked "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 FDA granted tentative approval for the short-acting insulin in September, with the agency nothing that approval was supported by safety and efficacy data from two late-stage studies including about 500 patients each.
"One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives," Gottlieb commented, adding "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."
The European Commission authorised the therapy as a biosimilar version under the name Insulin lispro Sanofi in July, while the European Medicines Agency's Committee for Medicinal Products for Human Use backed approval of the treatment in May.