The FDA Has Approved the First Generic EpiPen Alternative
The new product will offer a more affordable alternative to a life-saving drug
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EpiPens provide immediate, life-saving treatment to people with severe allergies, but the company that makes EpiPens has recently faced heated criticism for hiking up the price of its autoinjectors. Now, in order to introduce a more affordable alternative into the market, the Food and Drug Administration has approved a generic version of the EpiPen for the first time, report Carolyn Y. Johnson and Laurie McGinley of the Washington Post.
Teva Pharmaceuticals, an Israeli company, will manufacture the new generic version. Pharmacists will now be able to automatically swap prescriptions for EpiPen or EpiPen Jr. with Teva’s product. It is not yet clear how much the new drug will cost, or when it will become available. "We're applying our full resources to this important launch in the coming months and [are] eager to begin supplying the market," Teva spokesperson Doris Saltkill said in a statement.
The generic is, however, sure to be cheaper than the brand name EpiPen, which is owned by the company Mylan. EpiPens are injector devices that deliver doses of the hormone epinephrine that reduces swelling in the airways and increases blood flow in the veins when people experience a severe allergic reaction, or anaphylaxis, which can be triggered by things like bee stings, peanuts and medications. Epinephrine is inexpensive, and Epipens used to be fairly affordable too; when Mylan acquired the rights to sell the EpiPen in 2007, the drug cost around $100 for a two-pack.
In 2016, however, Mylan raised the price of its EpiPen two-pack to $600, according to Anna Edney of Bloomberg. After facing steep criticism from patients and lawmakers, Mylan introduced its own generic version that costs around $300.
More trouble came in May, when the FDA put the EpiPen on its list of drugs in shortage. Pfizer, which manufactures the EpiPen for Mylan, reportedly experienced disruptions in the St. Louis, Missouri, factory that makes all U.S. EpiPens, and more than 400 patients in 45 states reported difficulty in finding the drug, according to Edney.
There have been other alternatives to the EpiPen, like the Adrenaclick and the Auvi-Q, but they have by and large failed to find a foothold in the market. The Adrenaclick has faced its own manufacturing issues, while the Auvi-Q costs $4,500 for two autoinjectors, report Meg Tirrell and Leanne Miller of NBC News. Mylan also has the advantage of brand recognition; the EpiPen has been around since 1987, and has for many years been the most common method of injecting epinephrine.
Additionally, Mylan has fiercely protected its hold on the market, and has even been accused of acting illegally to shut down competition. Mylan pushed back against the advance of Teva’s new product, claiming that differences in the way the products function would be confusing to patients. For example, Mylan has a single, non-removable cap, but Teva’s generic has two, including one that is removable.
The FDA rejected Teva’s initial application in 2016, citing “major deficiencies,” according to Johnson and McGinley of the Washington Post. But in response to the Trump administration’s promises to cut drug prices, FDA Commissioner Scott Gottlieb has been working to remove barriers to the development of generic drugs.
The approval of the Teva generic is part of the FDA’s “longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” Gottlieb said in a statement. “This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.”