Thursday, July 20, 2017

Merck Gets FDA Nod For Sanofi Biosim Insulin Glargine Injection -- But Must Now Litigate The Patent, Under Hatch-Waxman

Merck has (as of January 2017) already been given an EU clearance on this insulin bio-sim, and if I recall correctly, it is on sale throughout the EU. This is part of Merck's co-venture with Samsung Bioepis, as we've long reported.

The news this morning is that Kenilworth cleared FDA (older February 2014 background on it, here; February 2013 backgrounder here), but now must litigate with Sanofi, under the relevant Hatch-Waxman (up to 30 month) stay period. Of course, Merck could win out -- in the federal patent case, and launch sooner -- we shall see. From the NASDAQ-filed press release then -- a bit:

. . . .The U.S. Food and Drug Administration has granted [Merck/Samsung Bioepis] tentative approval for LUSDUNA Nexvue or insulin glargine injection 100 units/mL, a follow-on biologic basal insulin in a pre-filled dosing device. LUSDUNA Nexvue is being developed by Merck with funding from Samsung Bioepis.

With the tentative approval, LUSDUNA Nexvue has met all required regulatory standards for follow-on biologics of clinical and nonclinical safety, efficacy and quality, but is subject to an automatic stay due to a lawsuit from Sanofi claiming patent infringement. . . .

To this moment, we haven't reported on that piece of patent litigation very closely (as it was immaterial to Merck, until it secured FDA approval) -- but now we obviously will cover it -- and do so, closely. I'll get up to speed, on it -- with the baby on my lap, in the Loop -- tonight. Smile.

To be clear, at least two other life science major players have one bio-sim in the cue -- so the field could get crowded (background on Dr. Gottlieb's new initiative at FDA, here), and prices could drop -- pretty quickly.

In fairness to the historical record, Dr. Gottlieb is mostly putting forward a slightly-tweaked version of an early ObamaCare era proposal -- one that sort of fell by the wayside, in 2014. The idea is sound, and would benefit US consumers immensely, so I don't care if a Trump appointee says it is "new" (when it is in truth a revision of a 2012-13 proposed FDA policy) -- it remains a good idea, even if I know it was originally conceptualized under Mr. Obama. Now you know. Onward, into the rain -- but smiling, just the same. . . . whoosh!


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