FDA pressed to act on biosimilar drugs

The Food and Drug Administration admits it has been slow to issue guidance on biosimilar drugs that are expected to hit the U.S. market next year. 


But Sally Howard, the agency’s deputy commissioner for policy planning and legislation, said the FDA is incredibly supportive of the new market, which experts say could lower prices of prescription drugs by 30 to 50 percent.

"Two companies have publicly announced that they’ve submitted applications for biosimilars and those are under review," she said. “There’s no additional guidance needed before an application can be approved.”

However, she said future guidance will be issued on labeling and interchangeable drugs. 

During an event Thursday hosted by The Hill and sponsored by Express Scripts, lawmakers called on the FDA and Congress to approve the use of biosimilars quickly.

“Healthcare reforms need to be patient-focused,” said Rep. Gus Bilirakis (R-Fla.). “Too often the regulatory structure in place gets in the way of innovation.”

Though healthcare professionals are hailing biosimilars for their potential to cut patient costs, the head of the National Association of Medicaid Directors raised concerns about whether the nation’s biggest healthcare provider will be able to afford the biological copycat drug. 

Medicaid as a payer is not equipped to pay the types of prices we’re seeing out there,” Matt Salo said. “Not just with the drugs to treat hepatitis C or cystic fibrosis, I’m talking about what’s in the pipeline.” 

But Lori Reilly, executive vice president for policy and research at Pharmaceutical Research and Manufacturers of America (PhRMA), said the notion that Medicaid prescription drug costs break the budget is misleading.

“Medicaid gets the best price in the market minus a 23 percent statutory discount and in most cases a supplemental rebate on top of that,” she said. 

“We’re ignoring the 96 percent of what Medicaid is spending its money on. Let's focus the debate on the facts and put it in the appropriate context.”

The panel also discussed the need for the FDA to issue guidance on naming biosimilars and address any health and safety concerns. Though biosimilars have been in use in Europe for the last seven years with no major adverse effects reported, Reilly said, “We shouldn’t let our guard down.”

FDA said it is focused on patient safety and patient access.

“Our goal as an agency is to instill confidence in these products and this industry,” Howard said.

This story was updated at 4:24 p.m.