Mylan’s EpiPen faces first copycat rival

Pittsburgh Post-Gazette

The U.S. Food and Drug Administration on Thursday approved the first direct generic competitor to Mylan’s EpiPen emergency allergy shot, delivering another blow to an important, if declining, revenue generator for the company.

Israel’s Teva Pharmaceutical Industries received the green light to sell generic versions of the EpiPen and the lower-dose EpiPen Jr. Teva had faced a long delay in winning the approval, having had its initial application rejected in early 2016.

Other epinephrine injectors have come on the market to compete with the EpiPen recently, such as the Adrenaclick and Auvi-Q, but none are authorized generic equivalents.

Mylan, which has its operations base in Cecil, started selling its own half-price generic version of the EpiPen in late 2016 after facing widespread backlash for hiking the price of the lifesaving device by some 500 percent.

More recently, Mylan has been struggling with supply shortages of the EpiPen tied to manufacturing issues at Pfizer, which makes the device for Mylan.

“Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. … 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,” the FDA said in its announcement.

Teva did not say exactly when it would begin selling its generic EpiPen, or how much it would cost.

“We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market,” Teva said in an emailed statement.

Teva’s shares added $1.64, or 7.3 percent, to close at $24.11 Thursday. Mylan’s shares edged up 3 cents, or .08 percent, to close at $37.85.