EpiPen Gets First Generic Rival After Furor Over High Price

(Bloomberg) -- EpiPen, a life-saving allergy treatment widely criticized for its high price tag, will get generic competition for the first time since the autoinjector was approved more than two decades ago.

The Food and Drug Administration on Thursday cleared Teva Pharmaceutical Industries Ltd.’s generic EpiPen and EpiPen Jr. for sale, several years after the Israeli drugmaker filed for approval. Mylan NV has attempted to thwart competition from Teva, claiming that differences in how the epinephrine-injecting devices work would confuse patients. While Teva’s device isn’t identical to the EpiPen, it will be fully substitutable at the pharmacy, the FDA said.

Mylan once took in about $1 billion a year in EpiPen sales, and before Thursday’s action it faced little direct competition. In July, Mylan’s products accounted for almost 75 percent of U.S. prescriptions for epinephrine autoinjectors -- similar to its market share in 2017, according to data compiled by Bloomberg Intelligence.

Teva’s American depositary receipts rose 6.9 percent to $24.03 at 2:33 p.m. in New York. Mylan fell 0.1 percent to $37.77.

FDA Commissioner Scott Gottlieb has pledged to help copycats of complex drug-device combinations like the EpiPen find a way to market. The strategy is part of a sweeping effort by the Trump administration to bring down drug prices with more low-cost competition.

Read more: Drug prices keep climbing as Trump steps up Twitter threats

Mylan bought the rights to EpiPen in 2007, when it cost about $57 a shot. The Canonsburg, Pennsylvania-based drugmaker came under fire two years ago from patients and U.S. lawmakers for raising the price of EpiPen to $600 for a two-pack of the autoinjecting pens.

Mylan then introduced an authorized generic version of its own device at $300 for a two-pack. In May, the FDA placed the EpiPen on its list of drugs in shortage after more than 400 patients in 45 states reported difficulty filling prescriptions following manufacturing issues at a Pfizer Inc. factory that makes the devices for Mylan.

“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,” Gottlieb said in a statement.

Teva said that it is working to get its version to market as soon as possible. It didn’t immediately provide a price. “We’re applying our full resources to this important launch in the coming months and are eager to begin supplying the market,” Teva spokeswoman Doris Saltkill said in an email.

Name Recognition

Mylan has faced competition from other similar autoinjectors -- Impax Laboratories LLC’s Adrenaclick and Kaleo Inc.’s Auvi-Q. However, neither are considered generics for EpiPen, which meant that pharmacists couldn’t substitute the products for the brand-name version at the drugstore counter. The two rivals haven’t sold nearly as well as EpiPen without name recognition. Adrenaclick is also on FDA’s shortage list.

Impax is now part of Amneal Pharmaceuticals Inc. Shares of Amneal fell 1.7 percent to $21.56.

The FDA previously rejected Teva’s generic EpiPen in 2016 after citing “major deficiencies” in the proposal. Unlike Mylan’s one-cap EpiPen, Teva’s proposed generic substitute had two caps, including a removable one that covers the spot where its needle extends. Mylan had argued that the difference in caps would confuse patients and could prove dangerous. It wasn’t immediately clear how the cap situation was resolved as part of Teva’s approval.

Ultimately, the agency concluded that the two devices, while not identical in design, were close enough to allow full substitution.

“The agency has concluded that any differences in design are not expected to affect the clinical effect or safety profile of the proposed product as compared to the brand drug, and that the generic product is fully substitutable for the brand product,” FDA spokeswoman Angela Stark said in a statement.

Mylan’s cap is nonremovable, a fairly recent innovation that prevents users from accidentally pricking themselves or others. Mylan argues that the updated cap along with other advancements are critical to the pen’s safety and functionality. It acquired new patents on the device that prevented others from copying its design until 2025.

For Mylan, the Teva approval is another problem to add to its list of financial woes. Earlier this month, the company reduced its financial guidance and said it would review its options as it deals with declining prices for many of its U.S. products.

In May, U.S. regulators said there were “intermittent supply constraints” of Mylan’s EpiPen, which could also be weighing on the drug’s sales.

--With assistance from Cynthia Koons.

To contact the reporters on this story: Anna Edney in Washington at aedney@bloomberg.net;Robert Langreth in New York at rlangreth@bloomberg.net

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Timothy Annett, Mark Schoifet

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