FDA grants final approval for insulin lispro injection follow-on product

The US Food and Drug Administration has approved Admelog(insulin lispro injection), the first follow-on (ie, a similar) insulin lispro to help people living with diabetes manage blood sugar levels at mealtime, from French pharma major Sanofi (Euronext: SAN).

Admelog is the first short-acting insulin approved as a “follow-on” product (submitted through the agency’s 505(b)(2) pathway), said the FDA. Sanofi’s shares edged up 0.7% to 74.11 euros this morning.

In September this year, Sanofi gained tentative approval of its product based on physicochemical, non-clinical and clinical similarity to another insulin lispro 100 Units/mL as currently approved in the USA, ie, Eli Lilly’s (NYSE: LLY) Humalog, which generated sales of $2.1 billion in the first nine months of this year.