Mylan Launches Generic EpiPen

Mylan pledges to manufacture affordable drugs in the midst of price-fixing allegations.

Mylan launched an authorized generic version of EpiPen (epinephrine injection, USP) Auto-Injectors in the United States last week.

The new generic EpiPen will be sold at a wholesale acquisition (WAC) cost of $300 per 2-pack of devices, which is 50% lower than the branded devices, according to a press release from Mylan. The generic option will be sold in pharmacies starting this week.

The authorized generic auto-injector contains the same drug formulation, and is administered in the same manner as the branded EpiPen.

“Americans are rightfully concerned about rising drug prices, and now more than ever patients and families across this country are standing at the pharmacy counter struggling to pay for their medications. While it is important to understand the outdated and complex system that determines what someone pays for medicine in the US, hardworking families don't need an explanation, they need a solution,” said Mylan CEO Heather Bresch in a press release. “This is why we took decisive action with our EpiPen product and have launched the first generic version at half the WAC price. This unprecedented action, along with the enhancements we made to our patient access programs, will help patients and provide substantial savings to payors [sic].”

The launch of the authorized generic version of the auto-injector is Mylan’s response to recent criticism over the cost of the branded product, which increased in price more than 500% in 10 years. This sparked outrage across the country, with many parents expressing fear that their child would experience an allergic reaction, and not have access to treatment due to the high cost.

Many individuals require the drug due to life-threatening allergies, but some had to face a choice of purchasing the EpiPen or using the $600 to purchase other the necessities of day-to-day life. Mylan believes that reducing the price of the drug to $300 will provide access to additional patients.

"Making quality medicines and making them accessible to patients has been our mission since Mylan began in West Virginia more than 55 years ago,” Bresch said. “As one of the world's largest generics companies, our medicines filled one out of 13 of all prescriptions in the US last year — the equivalent of 21 billion doses – which is more than Pfizer, Merck, AstraZeneca, J&J, Sanofi and GSK combined. We will continue to do our part to fight for changes that will make a difference in the lives of patients and remain deeply committed to serving patients in the severe allergy community by working to ensure that everyone who needs an EpiPen has access to one."

As a result of the EpiPen pricing scandal, US government officials have been looking into the company’s potential financial motives to increase prices.

Mylan even reached a $465 million settlement agreement with the Justice Department over allegations the company was overcharging Medicare and Medicaid for the EpiPen by wrongly classifying the product.

Last week, the company was included in a lawsuit filed by 20 states that allege the company, along with other generic drug makers, were engaging in price-fixing schemes that resulted in limited access to the medications.

However, this recent lawsuit was not mentioned in the press release where Mylan pledged their commitment to patient access to their life-saving drugs.

"Unfortunately, families will continue to face sticker shock for medications and may be forced to make difficult choices until the pharmaceutical pricing system is reformed to address the increasing shift of costs directly to consumers. Pharmaceutical pricing is too far removed from the patient at the pharmacy counter and not designed for today's increasingly consumerized [sic] healthcare system,” Bresch said. “Every day, escalating out-of-pocket costs impact a new patient population; however, this broader systemic issue will not be solved in a meaningful and sustainable way by our industry's one-off, reactive responses. This is an issue that will impact virtually every family on a high deductible plan, regardless of what medicine they are taking. That is why it is critical that all industry participants and government leaders come together to seize the opportunity to make fundamental changes to the system to ensure access to medicine.”