Merck's Lantus biosim MK-1293 gets closer to U.S. nod with new PhIII data

NEW ORLEANS--Merck & Co. won’t be the first to roll out a biosimilar version of Sanofi’s multibillion-dollar basal insulin, Lantus. But it aims to step up the competition when it does--and new data unveiled Monday back its case for approval.

In two separate, Phase III studies, MK-1293 stood up to Lantus (insulin glargine) at efficacy and safety in Type 1 and Type 2 diabetes patients. The Lantus copy hit its primary goal by matching the original med at reducing A1C, a standard measure of blood glucose control.

The med also met its secondary goal of statistical A1C equivalence to the brand, a measure used to show that the knockoff version is similar, within an acceptable range.

Merck’s Januvia franchise is well known as a standard diabetes treatment, but MK-1293 would be the company’s first foray into insulin therapies, said Dr. Peter Stein, Merck VP of late stage development in diabetes and endocrinology.

MK-1293 “showed a very nice reduction in A1C at similar doses and with a similar safety profile” to the originator med, Stein told FiercePharma at the American Diabetes Association Scientific Sessions here Sunday. “In both studies, we saw very nice results comparing MK-1293 to Lantus.”

Merck filed the Lantus biosim late last year for approval in Europe, and they’re planning to submit it to the FDA for approval this year. Assuming standard review times--and eventual approval--that would put MK-1293 on the EU market by year’s end, and would allow for a U.S. launch late next year.

In the Type 1 trial, which enrolled more than 500 patients, the mean difference in A1C between the two groups was 0.04%, Merck said in a statement. That number met requirements for non-inferiority in A1C control and equivalence. The mean difference in doses was 0.7 units per day.

On the safety side, there was “no meaningful difference,” Merck said, with symptomatic hypoglycemia cropping up in 76% of Lantus patients and 71% on MK-1293. The number of injection-site reactions was small and equivalent as well, Merck said.

Similar results were seen in the Type 2 trial, which also comprised more than 500 patients. The mean difference between the two drugs was 0.03%, Merck said, and the difference in doses was 1.4 units per day. Likewise, there were “no clinically meaningful” difference in safety endpoints, either; symptomatic hypoglycemia occurred in 52.1% of the patients using Lantus and 53.2% of those in the MK-1293 arm.

Eli Lilly & Co. and Boehringer Ingelheim rolled out their Lantus biosimilar in Europe last year, and, in the U.S., they’re preparing to launch it under the brand name Basaglar in December. Sanofi--and other competitors in the basal insulin market--will be watching closely to see how Lilly and Boehringer approach the rollout. The biosim makers might be able to score exclusive formulary spots in exchange for bigger discounts than those offered by other basal insulin brands--but how many, and how large the discounts might be, remains to be seen.

Merck is developing MK-1293, along with a range of other biosimilars, with partner Samsung Bioepis, but it retains worldwide marketing rights to the Lantus knockoff.

- see the release from Merck

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