- Troubled Mylan has issued an update on the ongoing U.S. shortage of its EpiPen epinephrine autoinjector, following manufacturing issues at Meridian Medical Technologies, a subsidiary of Pfizer.
- As a result of the problems, supplies of both the branded EpiPens and the authorized generics at pharmacies will be variable, and the autoinjectors may not always be available at all pharmacies.
- Mylan and Pfizer are working together to explore options "that would help stabilize supply," and both companies have committed to provide updates, and timings for resolution.
These manufacturing issues are not new news for Mylan. In March 2017, Mylan and its subsidiaries recalled batches of EpiPens in New Zealand and Australia, following manufacturing woes at Pfizer subsidiary Meridian Medical Technologies.
Recalls also took place in Japan and Europe, and then spread across more of the world, including more of Europe and Asia, North America and South America. In early 2018, the U.S. and Canada reported EpiPen shortages.
Meridian Medical Technologies received a warning letter from the Food and Drug Administration in September 2017, citing issues dating back more than a year.
"Meridian… continues to experience manufacturing constraints affecting U.S. supply," said a Pfizer spokesperson in a statement. "We are working tirelessly to increase production and expedite shipments as rapidly as possible. Currently, supplies will vary from pharmacy to pharmacy, and we cannot guarantee that product will be available at all pharmacies. We are actively exploring several options that would help stabilize supply."
"Our priority is to ensure patients with a life-threatening allergy have access to epinephrine auto-injector products. For our part, we are expediting shipments upon receipt from Pfizer. We also are working closely with Pfizer to stay informed of anticipated shipments and are maintaining regular dialogue with health authorities to provide frequent updates on supply status," a Mylan spokesperson said in a press release.
Mylan's EpiPen branded franchise is already under threat from a number of generics, including its own authorized generic.
Adamis Pharmaceuticals has made a deal with Sandoz, Novartis' generics unit, to commercialize the smaller company's epinephrine prefilled syringe in the U.S. Symjepi was approved in June 2017.
And rival Teva Pharmaceuticals just received approval Thursday from the Food and Drug Administration for their own generic version of the EpiPen.
And Kaléo Pharma's epinephrine auto-injector, Auvi-Q, was launched in early January 2017. Other upcoming competitors include Teva and Antares's Vibex epinephrine autoinjector, which has an abbreviated new drug application under review with the Food and Drug Administration.
Falling EpiPen sales were one of the drivers in the 22% decrease in Mylan's North American net sales in the second quarter of 2018, and the 20% fall in the first half of the year.
Earlier in 2018, the company had announced that its plans for the future were to focus on complex drug/device combinations and hard-to-copy biosimilars, but earlier this month it announced a strategic review committee, to assess a "wide range" of options.
This announcement provided little detail, so it's not yet clear where the business will go next, and the board said, in what could be seen as rather ominous tone, that there "can be no assurance" an alternative will be implemented.