Novartis’ Sandoz is getting ready to stir things up in the adult epinephrine market—and as of Thursday, it has a green light to stir things up in the pediatric epinephrine market, too.
The generics giant’s partner, Adamis, has snagged an FDA approval for a .15 mg dose of Symjepi, a prefilled syringe used for emergency treatment of severe allergic reactions. The smaller dose, which is half the volume of the .3 mg dose the agency OK’d last June, is meant for children who weigh between 33 and 65 pounds.
Sandoz, which is gravitating toward more complex products as pricing pressure hurts easy-to-make generic pills, will market the pediatric offering in the U.S., thanks to a July deal it struck with San Diego-based Adamis. The pact between the two also handed Sandoz distribution and commercialization rights for the larger dose.
For decades, Mylan’s Epi-Pen has dominated the epinephrine market, but in recent years, pricing scandals have opened the doors for low-cost competition. Adamis, which snagged the FDA’s favor after an initial rejection, last year pledged to position the not-yet-launched .3 mg version “as a low-cost alternative to the other current offerings in the anaphylaxis market,” an Adamis spokesman told FiercePharma via email.
The pediatric offering will also represent “an affordable alternative to current treatment offerings at a time when patients need access to this medicine most,” Sandoz President Carol Lynch said in a statement, adding that, “We are committed to reimagining their care by bringing this valuable, life-saving medicine in a prefilled epinephrine syringe to the U.S. market as soon as possible.”
That’s not to say grabbing market share will be an easy task. Lower-dose Symjepi will go up against not only a .15 mg dose of EpiPen, but a .15 mg dose of its generic, which Teva cleared with the FDA last month. Rival Auvi-Q from Kaléo also boasts a .15 mg dose, as well as the market’s only .1 mg dose for infants and toddlers. And it’ll be looking to keep patients who start on Auvi-Q as young children on the brand as they advance to the .15 mg dose.
Meanwhile, the competitive onslaught is coming at bad time for Mylan, whose EpiPen manufacturing woes have spurred a shortage and hurt shares. In response, the copycat drugmaker is conducting a strategic review, weighing options that could include a sale, execs have said.