Mylan's Copaxone copy could face another hold-up with FDA info request

Heather Bresch
Mylan CEO Heather Bresch said Wednesday that the company had received an "information request" from the FDA regarding its 20 mg Copaxone copy.

Mylan’s long-delayed Copaxone generic may be delayed even longer.

Wednesday at the Goldman Sachs annual healthcare conference, company CEO Heather Bresch acknowledged that Mylan had recently received an “information request” from the FDA over its knockoff of Teva’s 20 mg multiple sclerosis blockbuster.

“We’re responding to that in real time,” she said, noting that Mylan hoped to “bring you visibility and clarity on what that is” by the time its second-quarter earnings call rolled around.

The news clouds the approval picture for Mylan’s copycat. On the company’s first-quarter conference call, executives had said that the 20 mg product—like the company’s 40 mg generic Copaxone candidate—had a “target action date” in June, and “we see no reason that these dates cannot be met.”

And while Bresch said the candidate “absolutely could” still win a June approval and “doesn’t necessarily dictate” a discussion with the FDA, some analysts are doubtful.

“Our base case remains no Copaxone generic in 2017,” Evercore ISI Analyst Umer Raffat wrote in a note to clients.

The FDA’s info request follows an FDA rejection for Mylan’s that has kept it well behind a rival team of Momenta and Novartis’ Sandoz. That pair won a green light for its 20 mg copy Glatopa back in April, 2015, and the medication helped Sandoz’ biopharmaceuticals unit—which also includes biosimilars—rack up $772 million last year. 

RELATED: FDA details problems at Pfizer plant that derailed generic Copaxone approval

Things haven’t all been rosy for Momenta and Sandoz on the Copaxone front either, though. In February, they received an FDA warning letter over manufacturing issues that delayed their 40 mg approval beyond their expected first-quarter timeline.

Meanwhile, though, Teva has welcomed the delays with open arms. The Israeli drugmaker is struggling under industrywide generics pressure, questionable M&A moves and a slew of executive exits, making its Copaxone revenues all the more important.