Mylan and its EpiPen manufacturing partner Pfizer have had trouble keeping up with demand. That's not good news as the key back-to-school season nears.
Except, perhaps, for Novartis' Sandoz unit and its stepped-up rollout of rival epinephrine injector Symjepi. Amid a long-running EpiPen shortage, Sandoz and its partner Adamis are kicking off a broad retail launch for Symjepi.
Sandoz is making adult and pediatric doses of Symjepi available immediately at pharmacies, the drugmaker said Tuesday. Sandoz already launched the med in hospitals and has a sales force detailing it to hospital providers.
To bring patients into pharmacies, Sandoz has rolled out a social media program and a new website, Adamis said.
It's also hoping to push into schools, which are required in many states to stock epinephrine injectors in case students suffer severe reactions. But that's a tougher task. To make a big dent in that market, Sandoz and Adamis need some state lawmakers to tweak their regulations and change the definition of “auto-injectors.” Symjepi is a syringe, and current rules in some states force them to pay for the pricey EpiPen.
“Along with Sandoz, Adamis is thrilled to bring broad access to this critical medicine for patients,” Adamis CEO Dennis Carlo said in a statement. “We expect that Symjepi will play a role in ending the chronic shortages of epinephrine injection products in the U.S.”
EpiPen shortages popped up after an FDA inspection in 2017 found serious issues at the Pfizer plant where the auto-injectors are made. At the time, Pfizer said that Meridian, a subsidiary that manufactures the pens, was suffering "manufacturing constraints," but it was working with Mylan to improve "consistent availability." Amid an ongoing shortage, the FDA has worked with Pfizer and Mylan to extend EpiPen expiration dates.
Meanwhile, rival drugmakers have been working to push their alternatives with varying success.
And it's not just EpiPen that's running short now. Amneal said Wednesday it expects supply issues at a third-party provider to hit Adrenaclick sales during the critical third quarter when parents and schools stock up for the upcoming school year.
Sandoz and Adamis launched Symjepi early this year at $250 for a two-pack, compared with more than $600 for Mylan's EpiPen. Amid a pricing firestorm, Mylan launched a half-priced authorized generic in 2016.
Fierce competition in the market after Mylan’s EpiPen pricing firestorm spawned some questionable business practices, according to a recent lawsuit from Adamis. The company said that right after it won FDA approval for Symjepi, rival Kaléo bought up similar domain names and redirected traffic to its own Auvi-Q website. Kaléo didn’t respond to a request for comment from FiercePharma.