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Regulatory Focus™ > News Articles > FDA Looks to Close Loophole That Could Delay Approval of Biosimilars

FDA Looks to Close Loophole That Could Delay Approval of Biosimilars

Posted 10 March 2014 | By Alexander Gaffney, RAC

US regulators on Monday indicated that they are moving to close a regulatory loophole identified by legislators in 2012 that could prevent a biosimilar product from obtaining timely approval.

Background: FDAAA

In 2007, legislators passed into law the Food and Drug Administration Amendments Act (FDAAA), which contained a provision-Title IX, Section 914-that allows the US Food and Drug Administration (FDA) to disregard certain Citizen Petitions if their sole intent is to delay the introduction of generic or similar drug products.

Those products have historically been filed under either an Abbreviated New Drug Application (ANDA), or a new drug application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FD&C Act).

FDAAA's Section 914 added Section 505(q) to the FD&C Act. Per Section 505(q), FDA may delay approval of a product in the face of a Citizen Petition that raises questions requiring review in order to "protect the public health." Such delays can be as long as 180 days, per 505(q)(1)(F).

However, regulators are also permitted to deny a Citizen Petition if they determine that the intent of the petition is solely to delay another application, and does not raise "valid scientific or regulatory issues."

Background: FDASIA

In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was passed into law. Section 1135 of the law directed FDA to amend Section 505(q) of the FD&C Act to include an additional drug filing application: The 351(k) filing, otherwise known as the biosimilar application.

The section is intended to make sure biosimilar applications cannot be delayed by unnecessary Citizen Petition filing, most likely by rival companies. However, given the inherent differences between biologics and biosimilar products, companies will likely not be lacking for "valid scientific or regulatory issues" to put a competitor's filing on hold.

The law also decreased the time FDA has to reply to Citizen Petitions, from 180 days to the new 150 days.

Seeking OMB Approval

On 10 March 2014, FDA issued a Federal Register notice indicating that is seeking Office of Management and Budget (OMB) approval to amend its practices to prevent companies from unnecessarily delaying biosimilar applications.

Noting that it already has OMB approval to collect information on Citizen Petitions, FDA's latest submission to OMB updates its procedures to include 351(k) filings.

"Although the submission of a certification for citizen petitions is approved under OMB control number 0910-0183, the certification would be broadened under section 505(q) of the FD&C Act and the guidance," FDA wrote.

Comments on the submission are due to FDA by 10 April 2014.


Federal Register Notice

FDA 2011 Guidance on 505(q)

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