Federal regulators have given Mylan's EpiPen a new competitor as they green-lighted a cheaper alternative to the emergency allergy medicine.
The FDA on Thursday, June 15, gave its approval to Adamis Pharmaceuticals Corp.'s Symjepi, which is set to be available for sale later this year.
Epinephrine And Potentially Deadly Allergic Reactions
Just like EpiPen, Symjepi is a syringe that contains the hormone epinephrine to help stop potentially deadly allergic reactions.
Epinephrine, also known as adrenaline, can counteract the symptoms of anaphylaxis, a potentially fatal allergic reaction, by opening the airways to reduce breathing difficulties and swelling of the blood vessels.
The most common anaphylactic reactions are to insect stings, latex, medications and food. Up to 8 percent of children in the United States have food allergy, and about 38 percent of those with food allergy have had severe reactions. An epinephrine autoinjector serves as a lifeline for these people.
San Diego-based Adamis claims that its version of the allergy medicine is easier to use compared with EpiPen. The newly approved product is also smaller than EpiPen, which makes it easier to fit and carry in a purse or pocket. Just like EpiPen, Adamis's product will be sold in pairs.
Symjepi As Cheaper Alternative To EpiPen
Adamis said that it has not yet set the exact price for Symjepi. Adamis spokesperson Mark Flather, however, said that the company intends to offer the product as a low-cost alternative to Mylan's autoinjector and that it aims to make it available for less than the price of generic EpiPens.
"With an anticipated lower cost, small size and user-friendly design, we believe Symjepi could be an attractive option for a significant portion of both the retail (patient) and non-retail (professional) sectors of the epinephrine market," Adamis CEO Dennis Carlo said in a statement.
Adamis is also preparing to apply for approval of a junior version of its epinephrine injector, which will contain a lesser amount of epinephrine. Symjepi's junior version is set to compete with Mylan's EpiPen Jr.
Rising Cost Of EpiPens
EpiPens currently sell between $630 and $700 without insurance, and the new generic version is sold for about $225 to $425. The generic versions were launched last year to curtail mounting criticisms over the rising price of EpiPens.
A pair of EpiPens sold for only $94 in 2007 but the price skyrocketed to $608 last year. A pair of these devices is estimated to cost less than $20 to produce. What makes the purchase of EpiPens more burdensome is that these devices have to be replaced each year even though these may still work four years after their expiry date.
Mylan's Cash Cow
EpiPen is essentially a cash cow for Mylan, accounting for about 40 percent of the company's operating profits. In 2015 alone, about 3.6 million prescriptions were written for EpiPen.
Although EpiPen has other rival products, doctors are more likely to prescribe it. Pharmaceutical analytics company QuintilesIMS said that three years ago, EpiPens accounted for almost 90 percent of prescriptions filled in the country for epinephrine injectors and syringes.