The US Food and Drug Administration (FDA) approved its first biosimilar last week, giving Sandoz’s Zarxio (filgrastim-sndz) the thumbs up in a decision that was widely expected and seen as the breakthrough the copycat biologics sector was waiting for.
It remains to be seen if biosimilars take off in the US. What is certain is that they are already increasing the FDA’s workload.
Spokesman Kristopher Baumgartner told us the agency supports sponsors development efforts from an early stage through its Biosimilar Product Development (BPD).
“This includes holding development-phase meetings and providing written advice for ongoing development programs. FDA continues to meet with sponsors interested in developing biosimilar products” he said.
At the end of February this year, 50 versions of 15 originator products had been included in the BPD. Once a firm files a biosimilar through the 351(k) pathway it leaves the BPD.
To date only Sandoz, Apotex and Celltrion have publicly announced that they have filed biosimilars for review.
Funding
The US established a biosimilar review pathway in March 2010 through the Biologics Price Competition and Innovation Act of 2009 (BPCIA). However, while this gave the agency a regulatory outline it did not allocate funds.
It was not until President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law in 2012 that a funding programme was put in place through the Biosimilar User Fee Act (BsUFA).
BsUFA was set up to provide the FDA with user fee revenue to expedite the review process, including applications, supplements, notifications, responses and meeting management.
At least, that was the plan.
According to Baumgartner “The biosimilars review program was an under-resourced program for the first few years while the biosimilar industry built itself up.”
The agency is now confident the user fees will provide sufficient funding. Baumgartner told us: “The FDA expects that the BsUFA program will continue to become more fully resourced for the steadily increasing workload.”
Inspections
In addition to reviewers, biosimilars will also create more work for FDA inspectors according to Baumgartner who said: “It is likely that more biosimilar marketing applications will mean more facilities that need to be inspected by the FDA.
“However, we cannot provide an estimate of the number of facilities that would need to be inspected” he added, explaining that the number of inspections will be linked to the number of applications and any new plants or manufacturing is involved.