Teva Pharmaceutical Industries, the Israel-based generic drug giant, will report its financials this week amid uncertainty following the presidential election and increased competition by rival Mylan Pharmaceuticals on a generic EpiPen.
A Teva spokeswoman declined to comment on the results of the election, but other drugmakers have largely opposed President-elect Donald Trump's positions on cost transparency and direct negotiations with Medicare on drug prices.
Some believe a Trump administration would enact reforms to speed up drug approvals by the Food and Drug Administration. Jim Shehan, a former FDA official and head of Lowenstein Sandler's FDA regulatory practice, said current laws are favorable to generic drugmakers like Teva, and he believes the next administration will continue to have a pro-generic sentiment.
Teva has tried for years to get FDA approval for a generic version of U.K.-based Mylan's EpiPen. Teva initially expected to gain approval in summer 2015, but so far has been unsuccessful. Mylan has filed petitions with FDA expressing concern that differences between the branded product and generic could impact patient safety.
But Mylan may beat Teva to the punch, as CEO Heather Bresch announced a December release date for Mylan's own generic EpiPen. Teva may face stiff competition, especially if the company can't beat Mylan's $300 price tag, let alone get the generic approved.
