As a second step in less than a week to counter the backlash over the product’s steep price, the first generic version of its allergy auto-injector EpiPen for $300, half the price of the branded product, Mylan NV said.
In a move that that U.S. lawmakers and Presidential candidate Hillary Clinton said was not enough, the list price was kept at about $600 while the company reduced the out-of-pocket costs of EpiPen for some patients on Thursday. EpiPen cost about $100 in 2008.
In an unusual move considering the branded bestseller is still patent protected and major rival treatments have failed to get regulatory clearances, Mylan said on Monday it expected to launch the generic product “in several weeks.”
Its latest move raised as many questions as solutions, including why the price is still astronomically high and whether its action is a preemptive strike against a competing generic, said Democratic senator Richard Blumenthal adding that Mylan may appear to be moving in the right direction.
“Investigations are still vitally necessary into possible antitrust lawbreaking, and I will press for Senate hearings as well as FTC subpoenas,” Blumenthal said in a statement. Democratic senator Amy Klobuchar echoed the call for an investigation.
Claiming that it had spent hundreds of millions of dollars to improve the product since acquiring it in 2007, Mylan has defended EpiPen’s high price.
Since benefit managers which often require discounted prices or rebates from drugmakers, along with insurers and others are involved, the company recoups less than half the list price, it has said.
“Our decision to launch a generic alternative to EpiPen is an extraordinary commercial response. We determined that bypassing the brand system in this case and offering an additional alternative was the best option,” Chief Executive Heather Bresch said Monday.
Mylan’s latest move was another “convoluted mechanism to avoid plain talk, admit to price gouging and just cut the price of EpiPen,” said consumer watchdog group Public Citizen.
“The weirdness of a generic drug company offering a generic version of its own branded but off-patent product is a signal that something is wrong,” President Robert Weissman said.
Clocking at $43.17 in midday trading, Mylan’s shares were little changed. Amid a wave of criticism over prices of EpiPen, the stock had fallen 12 percent last week. EpiPen generates annual sales of $1 billion and dominates the market.
The generic launch was “the big one” and would help PBMs cap their costs even though Mylan had “infinite possibilities” to handle the outcry over EpiPen prices, said Bernstein analyst Ronny Gal.
However, he expects U.S. health regulators to face more pressure to approve competing treatments and Mylan to still come under fire for its prices.
Teva Pharmaceutical Industries Ltd’s generic version earlier this year and Adamis Pharmaceuticals Corp’s rival treatment in June were rejected by the FDA. On concerns of inaccurate dosage, Sanofi SA has pulled its device from the market last year.
Since they expect the launch of Teva’s version in 2018 to become a pricing headwind, the generic launch only removed a near-term pricing lever for Mylan, said Leerink Partners.
(Adapted from Reuters)