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The partial government shutdown is affecting the country in many ways-but how is it interfering with biosimilar development?
As we enter week five of the partial government shutdown, the effects across the country are growing exponentially-and the biosimilar market is not exempt from those issues.
FDA commissioner Scott Gottlieb, MD, who heads is one of the nine federal agencies shuttered during the current Congressional budget dispute, announced via Twitter that the organization had enough carryover funds to continue working on drug applications submitted and paid for prior to December 22, 2018 for a few weeks, but no new applications could be taken at this time. But those few weeks of funding wiggle room are quickly. running out. And Julie Rubin, PharmD, BCPS, director of clinical services for CompleteRx, a pharmacy management consultancy, says that companies who are pursuing biosimilar approval and commercialization should be on guard.
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“This is a situation that can affect biosimilar development in many different ways,” she says. “With approximately 40% of people furloughed in these agencies that help across the biosimilar process, you have to expect they are working at bare bones-and that means that there will be impact.”
Here are three ways the government shutdown is affecting biosimilar development.
1. FDA Approvals
Best estimates suggest that the FDA only has a few weeks of funding left. If the government fails to end the shutdown soon, pharmaceutical companies should expect that drug approvals will be significantly delayed.
“If you already paid your fee, you may be okay. You may get in under the wire,” she says. “But if your drug is in the pipeline about to go the FDA, you’re probably looking at being at some kind of waiting list until the government is back in business. And every single day an approval is delayed, your company is losing money.”
She suggests that companies that are looking to launch a biosimilar product carefully reexamine their launch plans, because even when the government reopens, there will still likely be delays.
“Once the government starts back up, there is going to be back-up. The FDA will have to play catch-up, and may have to prioritize what they try to push through,” Rubin explains. “You need to be prepared for that possibility.”
2. Patent approvals
Like the FDA, the U.S. Patent and Trademark Office (USPTO) is also using carryover fees to extend their operating status during the lapse in federal funding. And also like the FDA, pharmaceutical companies should expect patent approvals to be put on hold.
“The people who approve patents, who release and expire patents, they are all affected by this shutdown,” she says. “That’s also going to slow biosimilar development down.”
The U.S. Department of Justice is also affected by the partial shutdown. Rubin says this is a concern to the biosimilar community due to the ongoing litigation and legal red tape.
“As companies develop their timeline and their strategy for commercialization, many do consider how long it may sit in litigation before it’s actually approved,” she says. “But as funding dwindles, the courts are going to have to stratify what kind of cases they are hearing. Civil cases, like these drug approvals, will probably fall to the bottom of the list and remain pending until the government is fully opened.”
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Since there’s no telling how long the shutdown will continue, Rubin says it’s important that companies consider where their biosimilar products may be affected and take a “wait and see” approach-while still taking steps to protect their investments.
“You have to be very aware of the different steps and the different pieces that you’ll have to manage as this continues,” she says. “Because even when the government starts back up, things are still going to be in limbo for a while.”
Kayt Sukel is a science and health writer based outside Houston.