- The Washington Times - Thursday, August 16, 2018

The Food and Drug Administration on Thursday approved the first generic competitor to Mylan’s EpiPen, offering allergy sufferers the possibility of a lower-cost option than the brand name drug that drew scrutiny after price hikes.

FDA Commissioner Scott Gottlieb, insurers and advocates said the copycat device from Teva Pharmaceuticals, an Israeli company, could be a lifeline for patients looking to save money and access vital medication, after Mylan reported supply shortages with its manufacturing partner, Pfizer.

“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,” Dr. Gottlieb said.

Teva, whose stock price jumped about 6 percent upon the news, hailed the approval as an “important step” and said it will be “applying our full resources to this important launch in the coming months and eager to begin supplying the market.”

The company didn’t reveal its prices, so it’s unclear if it can offer a better deal than Mylan, the brand-name company that took on withering criticism for hiking the price of its injector twin-pack from about $100 in 2009 to more than $600 by 2016.

Under pressure from Congress, Mylan didn’t slash prices, but did expand its assistance programs for needy families and launched a generic version of its own pens at half-price, or $300.

The company was also forced to pay hundreds of millions to settle claims it shortchanged taxpayers by misclassifying its device as a generic instead of a brand-name product under Medicaid.

Mylan did not return a request for comment on FDA’s approval of Teva’s copycat.

With an injection to the thigh, EpiPens stave off life-threatening anaphylaxis from peanuts, bee stings or other allergy triggers. Users typically carry the pens with them at all times, and a number of states require schools to have them on hand.

That prominence led to accusations that Mylan was abusing its monopoly status with the price hikes.

Jen Madsen, chief of staff at Food Allergy and Research Education, said Teva’s entry into the market with an exact copy of the EpiPen was exciting news.

“Having another option — particularly one that has the same ‘look and feel’ as the Mylan EpiPen — should make the Teva product a popular choice, once it becomes available,” she said.

She also said FARE hopes the pricing will make it an attractive option.The top health insurers’ lobby also called Teva’s announcement a good sign.

“We need to continue to build on these types of efforts and pave a path for a robust generic market to continue to create competition and reduce prices,” said Cathryn Donaldson, spokeswoman for America’s Health Insurance Plans.

Dr. Gottlieb said there are other epinephrine auto-injectors on the market, but Teva’s version is the first direct replica of the EpiPen that can be directly substituted at the pharmacy counter.

He said the approval is an outgrowth the agency’s push to help drug makers devise generic versions of complex products.

The EpiPens were especially hard to copy, he said, because they are a “combination” produce consisting of a drug — the epinephrine — and a device, the auto-injector.

Speeding generic competitors to market is a key plank of President Trump’s plan to slash drug prices, which also includes moves to inject negotiation into segments of Medicare and, in some cases, a stern tweet or phone call from the president.

Mr. Trump on Thursday said his changes to drug pricing are making Big Pharma unhappy but he’s not going to back down against the powerful lobby.

“I don’t need their money,” Mr. Trump said during a cabinet meeting. “They don’t like me too much right now.”

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