Newly Approved Generic Version of EpiPen Is Not Cheaper Than Available Option

Teva pharmaceutical industries ltd recently said that its generic of EpiPen (Mylan N.V.) is now available in limited quantities in the United States after being granted FDA approval in August 2018.¹ This is the first approval of a direct generic copy of the widely prescribed epinephrine auto-injector.²

Epinephrine injection is a prefilled auto-injection used as an emergency treatment for allergic reactions, such as anaphylaxis, in those with serious allergies. The device reduces swelling of the airway and prevents suffocation, and increases the blood pressure and heart rate, in a patient in anaphylactic shock.¹

The generic epinephrine injection will be publicly available in 0.15-mg and 0.3-mg prefilled doses at a wholesale price of $300 for a pack of 2 auto-injectors, according to a statement from Teva Pharmaceutical Industries.¹ Although the generic version of EpiPen was anticipated as an option to address shortages and reduce costs for patients, Teva Pharmaceutical’s epinephrine auto-injector is the same price as Mylan N.V.’s authorized generic EpiPen, according to the statement.^1,3

EpiPen has risen from $100 in 2007 to $608 for a 2-pack, a 600% increase in price. The continuing increase resulted in heavy criticism of Mylan, prompting the company to act. In December 2016, the company started offering a generic EpiPen listed at $300, half the price of the brand-name auto-injector but still 300% more expensive than the price in 2007.³

The generic approval for Teva Pharmaceutical’s epinephrine auto-injector was initially seen as a win by some who thought that it would make epinephrine injections more affordable than Mylan’s options.²

“This approval means patients living with severe allergies who require constant access to lifesaving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages,” FDA Commissioner Scott Gottlieb, MD, said in a statement announcing the approval.²

Although the new generic may not end up reducing the cost of epinephrine injectors, it can help address the issue of drug shortages. There has been a Mylan EpiPen shortage since May because of what the company has described as issues at a Pfizer plant where the auto-injectors are manufactured.⁴

Gottlieb said that companies have had difficulty manufacturing generic copies of EpiPen, but the FDA hopes to make it easier to develop generic versions of these complex drug devices with the Drug Competition Action Plan, according to the statement.²

“We’re especially committed to the development of generic copies of complex products. These products can be hard to copy and therefore sometimes don’t face timely generic competition once patents and exclusivities are no longer a block to approval,” Gottlieb said.²

Representatives from Teva Pharmaceutical, an Israeli company, believe that the its addition to the market will give patients better access during shortages. “We’re pleased to provide access to epinephrine injection for patients who may experience life-threat- ening allergic emergencies, and we’re fully dedicated [to] ensuring additional supply in 2019,” said Brendan O’Grady, executive vice president and head of North America Commercial at Teva Pharmaceutical.¹

REFERENCES

• FDA approves first generic version of EpiPen [news release]. Silver Spring, MD: FDA; August 16, 2018. fda.gov/newsevents/newsroom/pressannouncements/ ucm617173.htm. Accessed December 14, 2018.
• Teva’s generic version of EpiPen (epinephrine injection, USP) auto-injector 0.3 mg now available in limited quantity in the United States [news release]. Parsippany, NJ: Teva Pharmaceutical Industries; November 27, 2018. businesswire.com/news/ home/20181127005573/en/Teva’s-Generic-Version-EpiPen®%C2%A0-Epinephrine- Injection-USP. Accessed December 14, 2018.
• Mylan launches the first generic for EpiPen (epinephrine injection, USP) auto-injector as an authorized generic. Mylan website. mylan.com/en/news/fea- ture-stories/mylan-launches-authorized-generic-epipen. Published December 16, 2016. Accessed December 14, 2018.
• Updated Mylan statement on U.S. supply of EpiPen (epinephrine auto-injection, USP) auto-injectors from Meridian Medical Technologies, a Pfizer Company. Mylan website. newsroom.mylan.com/press-releases?item=123590. Published August 8, 2016. Accessed December 14, 2018.