FDA Kicks Off BsUFA Reauthorization Talks

December 28, 2015

The FDA’s first public meeting on the 2017 reauthorization of the Biosimilars User Fee Act brought calls for increased transparency in terms of how the agency regulates biosimilars and a rethinking of how these products will be named.

PhRMA’s Michael Levy voiced support for product labeling that distinguishes biosimilars from their reference products, a subject of interest to nearly every speaker at the meeting, including Angus Worthing of the American College of Rheumatology.

Worthing spoke out against the FDA’s draft guidance in August to give biosimilars the same basic nonproprietary name as the reference product, but with a unique, four-letter suffix tacked on the end to distinguish them. He said each biosimilar should have a unique name.

Mary Jo Carden of the Academy of Managed Care Pharmacy said much the same, contending that the agency’s proposal would result in confusion for patients, healthcare providers and others.

She also voiced support for putting user fee funds toward postmarketing surveillance and efforts to educate patients and physicians about the safety and efficacy of biosimilars.

Other speakers concentrated on the cost issue, saying biosimilars are needed to offer the market more affordable alternatives to expensive medications.

“The costs associated with biologics [and drugs] are not sustainable,” said Leigh Purvis with AARP. “Medical advances are meaningless unless people can afford them.”

To incentivize the market for biosimilars, she recommended that the agency lower the user fees with the reauthorization.

FDA officials in attendance also expressed their hopes for the program. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, said the program needs to be better funded to ensure that scientists and reviewers aren’t lured away by more lucrative offers from industry.

“We do have challenges in recruiting and training staff for biosimilar development programs,” she admitted. “This is very complicated science,” she said, adding that experts in the field are in high demand.

She noted that even though only one biosimilar product has been approved thus far — the cancer drug biosimilar Zarxio — 59 additional biosimilar applications have been filed with the agency as of December.