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Mylan set to launch generic EpiPen

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Drug maker answers public's call for more affordable product

PITTSBURGH — In what chief executive officer Heather Bresch called “an extraordinary commercial response,” Mylan N.V. plans to release a generic version of its EpiPen epinephrine auto-injector for anaphylaxis, answering public demands to lower the cost of the potentially life-saving product.

Mylan said Monday that its U.S. subsidiary expects to roll out the generic EpiPen Auto-Injector in several weeks, after labeling revisions. The generic product will carry a list price of $300 for a two-pack carton, a discount of more than 50% to the Mylan list price, or wholesale acquisition cost, of the branded medicine.

EpiPen_patient with box_MylanThe authorized generic will be identical to the branded product, including device functionality and drug formulation, Mylan said. The generic will be available as a two-pack carton in 0.15-mg and 0.30-mg dosages. The company added that it will continue to market and distribute the branded EpiPen product.

Mylan’s introduction of an EpiPen generic comes amid a public furor over a steep price hike for the product in recent years.

Last week, U.S. Senate leaders complained that EpiPen’s price has surged 400% — from about $100 for a two-injector pack to over $500 or $600 — since Mylan acquired the product in 2007. The lawmakers reported that they had fielded numerous complaints from consumers, who noted that the cost burden is exacerbated because the medication expires in about a year.

The ease-of-use and reliability of EpiPen’s auto-injector have made the product an essential emergency treatment for anaphylaxis, a possibly life-threatening allergic reaction. The product has been the only one of its kind available since Sanofi’s Auvi-Q was pulled from the market in 2015 due to dosing issues. Mylan markets and prices EpiPen, which is manufactured by a Pfizer Inc. subsidiary.

“We understand the deep frustration and concerns associated with the cost of EpiPen to the patient and have always shared the public’s desire to ensure that this important product be accessible to anyone who needs it. Our decision to launch a generic alternative to EpiPen is an extraordinary commercial response, which required the cooperation of our partner,” Mylan’s Bresch said in a statement. “However, because of the complexity and opaqueness of today’s branded pharmaceutical supply chain and the increased shifting of costs to patients as a result of high-deductible health plans, we determined that bypassing the brand system in this case and offering an additional alternative was the best option.”

On Thursday, Mylan announced efforts to reduce the cost of EpiPen to patients. The company introduced a new savings card covering up to $300 for an EpiPen 2-Pak, halving the out-of-pocket cost for patients who had been paying the full EpiPen list price and increasing the discount from the $100 savings card previously offered. Mylan also doubled the eligibility for its patient assistance program for EpiPen.

Lawmakers, however, said those cost reduction efforts didn’t go far enough. “The announcement today doesn’t appear to change the product price,” Senate Judiciary Committee chairman Chuck Grassley (R, Iowa) said in a statement Thursday. “The price is what Medicare, Medicaid and insurance companies pay. It’s what patients who don’t get assistance cards pay. And when drug companies offer patient assistance cards, it’s usually not clear how many patients benefit.” Grassley and four other senators had sent a letter to the Food and Drug Administration asking about the process for approving alternatives to EpiPen in light of the product’s cost.

Bresch noted that the release of a generic version of EpiPen demonstrates Mylan’s commitment to ensure that patients who need the product can get it. “The launch of a generic EpiPen, which follows the steps we took last week on the brand to immediately reduce patients’ out-of-pocket costs, will offer a long-term solution to further reduce costs and ease the burden and complexity of the process on the patient,” she commented.

Mylan said the expanded patient assistance program and the $300 savings card announced last week for EpiPen will remain in place for the branded product, as will the EpiPen4Schools program.

The company added that it plans to commence a direct-ship program with the launch of the generic at the $300 list price and broaden access to epinephrine auto-injectors through such measures as including the product on federal and private insurance preventive drug lists, which could eliminate all co-payments.


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