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Regulatory News | 04 February 2016 | By Zachary Brennan
Shuttling back and forth between two different House committee hearings on Thursday, US Food and Drug Administration’s (FDA) CDER Director Janet Woodcock made clear in a later hearing on biosimilars that the agency needs Congressional appropriations to properly run its biosimilar review program.
When the Biologics Price Competition and Innovation Act (BPCIA) was enacted in 2010, FDA received no additional congressional appropriations to run the program, Woodcock said, forcing the agency to take $20 million in existing funds from other activities, including work on over-the-counter monographs and compliance activities.
And although the biosimilar market in the US at the time of the BPCIA’s enactment was non-existent, Woodcock explained how the user fee program set up by the legislation has only steadily provided funding to FDA – from $6 million in FY2013 to $13 million in 2014, to almost $24 million in 2015.
“I’m concerned this program is going to explode,” Woodock said, referring to the fact that FDA doesn’t have the staff to keep up and is always playing catch-up with companies submitting biosimilar applications, though more funding will come in as the market becomes more robust in the US.
So far, only one biosimilar has been approved for the US market by FDA.
“Biologics [and biosimilars] are like the Empire State building, compared to a regular drug, which is like a house,” Woodcock explained. “Biologics are not exactly the same from batch to batch as the cells are subject to conditions we can’t fully control. Our job in regulating them is to make sure variabilities don’t impact safety or effectiveness.”
Next Tuesday, an FDA advisory committee will discuss Celltrion’s Remsima, which is biosimilar to Johnson & Johnson’s Remicade (infliximab) and could offer more insight into FDA’s review process for biosimilars. Woodcock noted that there are almost 60 biosimilar programs under development in various stages and several dozen other companies have reached out to FDA about possible other biosimilar applications.
“People are anxious to see more progress and certainty,” she added.
As far as FDA releasing more guidance for biosimilar developers, Woodcock reiterated that labeling and interchangeability guidance is expected this year.
And even though interchangeability guidance has yet to be issued, Woodock said the agency “may approve a biosimilar as interchangeable without such guidance,” perhaps indicating that a company has applied for such a designation.
On the government reimbursement side of biosimilars, Sean Cavanaugh, deputy administrator and director for Medicare in the Centers for Medicare and Medicaid Services (CMS), was grilled by Energy & Commerce representatives about CMS’ final rule on billing codes for biosimilars.
Cavanaugh made clear that the coding system has “a modifier specific to each manufacturer, so they’ll know which company made the product,” and thus FDA will be able to track the manufacturer for each biosimilar. “Physicians don’t order biologics by billing code,” he added.
Energy & Commerce Committee Hearing
Tags: biosimilars, BPCIA, biologics, Remsima, Celltrion