Follow-on biologics have 3 years to change the FDA culture (and that’s just fine)

There’s been lots of good news for biologics lately. Among them: the leadership of the U.S. Food and Drug Administration isn’t leaving.

Even when a president wins a second term, there’s typically some turnover in federal offices. This hasn’t happened at the FDA this time around. Craig Wheeler, president and CEO of Momenta, thinks that the fact the FDA leadership won’t change much in President Obama’s second term is a great sign for his company and others preparing generic biologics.

“There are many positive things in the FDA right now,” Wheeler said Monday in an off-site meeting at the JP Morgan Healthcare Conference in San Francisco. “Elevating the (Office of Generic Drugs or OGD) to a super office. The co-location of OGD and (Office of New Drug Chemistry) so they get that interaction. Historically they’ve been very siloed.”

Wheeler said that while the FDA’s leaders are in favor of biologic generics, it will take time for that same attitude — and a comfort level of how to put biologics through a smoother approval process — to filter down through the rest of the agency.


So biologic companies like Momenta have about three years to change the culture at the FDA?

“That’s fair,” Wheeler responded. “But that’s plenty of time.

“The leadership — the general leadership — is biased toward the generic side,” Wheeler added. Now, he said, they need to “transplant that to the rest of the agency.”

Momenta’s biggest win in 2013, however, wouldn’t come through the FDA. It would come through the courts — where it’s had some pretty mixed results.

Wheeler said the big breakthrough this year would be approval to market their generic version of Teva’s multiple sclerosis treatment Copaxone. Teva is hoping to keep Momenta (and Mylan) from selling a generic version until as long as 2015. Momenta is appealing, and a ruling would open up a drug that has roughly 40 percent of U.S. market share and generates $4 billion in revenue for Teva.

“It would show we could not only work in sugars but also in peptides,” Wheeler said.

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