FDA Grants Final Approval to First Short-Acting Follow-on Insulin, Admelog

The FDA has granted final approval to the first short-acting follow-on insulin product, Sanofi’s Admelog (insulin lispro injection). Admelog is indicated to improve insulin control in blood sugar levels in adults and children aged 3 years and older who have type 1 diabetes and in adults who have type 2 diabetes.

"Admelog will offer a more affordable option for those who require control of their blood sugar levels at mealtime," said Stefan Oelrich, executive vice president and head, global diabetes and cardiovascular, Sanofi, in a statement. "The approval of Admelog is an important milestone for Sanofi in our mission to serve patients living with chronic diseases such as diabetes."

FDA Commissioner Scott Gottlieb, MD, added, “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. 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.”

Final approval of the drug follows the FDA’s tentative approval, granted in September 2017. The agency did not issue its final approval until the resolution of patent disputes with the reference Humalog’s sponsor, Eli Lilly.

Admelog’s tentative approval was based on its similarity to the innovator Humalog. However, because the FDA treats innovator insulins as drugs, rather than as biologic products, treatments such as Admelog are regulated as “follow-ons,” not as biosimilars. The European Union addresses these products differently; Admelog is approved by the European Medicines Agency as a biosimilar insulin product, and the drug is marketed in the European Union under the proprietary name Insulin lispro Sanofi.

However, as Scott Lassman, JD, partner at Goodwin’s technology and life sciences group, explained to The Center for Biosimilars^® in a recent interview, “Very soon, in 2020, all those products, like insulin, which are now regulated as drugs and get approved through [New Drug Applications] and 505(b)(2) applications, they’re all going to be transitioned to biologics and they’re going to have to submit [Biologics License Applications]. So, this [follow-on] issue won’t exist for much longer.”