Merck’s Lantus Biosimilar Queued for an FDA Submission?

Merck, known as MSD outside the United States and Canada, announced promising results from two Phase III studies evaluating MK-1293  – Merck’s biosimilar to Lantus (insulin glargine).  Lantus is used for the treatment of people with type 1 and type 2 diabetes.  In both Phase III studies, MK-1293 demonstrated statistical equivalence in efficacy and similar safety to Lantus after 24 weeks in patients with type 1 and type 2 diabetes.

Merck filed the Lantus biosimilar for approval in Europe late last year.  With these results, Dr. Peter Stein, Merck’s VP of late stage development in diabetes and endocrinology, stated, “[a]s a follow-on biologic, MK-1293 has the potential to offer a treatment option for pediatric and adult patients with type 1 diabetes and for adults with type 2 diabetes who use basal insulin to help control their glucose levels.”  Assuming standard review times (and approval), MK-1293 could be on the EU market by the end of the year.  With the promising Phase III results, Merck may also soon be gearing up for submission of MK-1293 to the FDA.

Stay tuned to the Big Molecule Watch blog for further developments.