FDA OKs Sanofi follow-on biologic
FDA OKs Sanofi’s follow-on biologic of Lilly’s diabetes drug Humalog
The U.S. Food and Drug Administration said on Monday it approved Sanofi SA’s Admelog as the first follow-on biologic version of Eli Lilly and Co’s fast-acting insulin, Humalog.
Admelog, generally taken just before meals, was approved for use in children older than three and adults with type 1 diabetes, as well as adults with type 2 diabetes.
Like Humalog, which earned Lilly $696.2 million in the latest quarter, the short-acting drug helps diabetics control blood sugar levels after eating.
Additionally, diabetics may need a long-acting insulin treatment to prevent blood sugar levels from fluctuating through the day.
Patients with type 1 diabetes require both types of insulin, while those with type 2 may not need a short-acting insulin.
Admelog’s approval bolsters Sanofi’s position in the diabetes treatment market after its blockbuster drug Lantus, a long-acting insulin, lost U.S. patent rights in 2015.
According to the Centers for Disease Control and Prevention, more than 30 million people in the United States have diabetes.
(Reporting by Tamara Mathias in Bengaluru; Editing by Anil D’Silva)