Blog Big Molecule Watch June 16, 2016

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.