ICYMI: 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 actually submitted applications 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.

To read the article it its entirety online, click here.