Data Submitted Before 2010 shouldn't be Used to Approve Biosimilars, Group Says

Posted 19 April 2013 | By Alexander Gaffney, RAC 

A prominent conservative legal group is calling on the US Food and Drug Administration (FDA) to refrain from using certain information to approve biosimilar products, saying that it believes that same information was originally provided to regulators as a "trade secret," and should accordingly not be used.


The problem to which the Washington Legal Foundation (WLF) is referring in its 17 April 2013 comment to FDA dates back to 2010, when President Barack Obama signed the Patient Protection and Affordable Care Act (PPACA) into law.

That legislation, more commonly referred to as "Obamacare," contained a collection of regulatory provisions known as the Biologics Price Competition and Innovation Act (BPCI), which established a pathway for the eventual introduction of biological products that are similar to an already-approved reference drug.

These products, known as biosimilars, follow-on biologics or similar biological products, are meant to achieve the same goals as their chemically-based generic pharmaceutical counterparts: Bring down the high costs of drug products by allowing competition.

Another similarity created by the law has to deal with a period of market exclusivity. Under the BPCI, biological products would also be given a defined period of exclusivity during which generic products could not be introduced, but with one key difference: 12 years of market exclusivity instead of just five, which is the standard for new chemical entities.

A Problem of Data

Left undefined by the law, however, is what data FDA will actually be allowed to use to approve biosimilar drugs.

The problem doesn't so much affect data that will be submitted going forward-the law is rather clear on the point-but instead covers data already submitted to the agency for biological products that would be among the first to lose protection against biosimilar products.

WLF mirrors arguments made last year by the biopharmaceutical manufacturer Abbott in that company's citizen petition, arguing that submissions made before the passage of the BPCI were made in the understanding that data-analytical, preclinical, clinical and manufacturing process-was a trade secret protected by FDA.

"Under well-established trade secret law, use of trade secrets that results in diminution in the value of the secrets violates the property rights of the trade secret owner," WLF argues in its brief. Since that understanding no longer exists after the passage of the BPCI, all companies with new applications aren't under that understanding, and would thus be free, if they wanted, to exclude information from the application or not submit the application at all.

But pre-BPCI companies were operating under a very different mindset, WLF argues, and "would very reasonably have believed that their trade secret information would not be used to assist their competitors in this manner."

"Until such time as FDA determines, after careful consideration, that the sponsor of the pre-March 2010 reference product at issue reasonably expected that FDA might use its trade secrets to assist competitors, it should not approve an application to market a biosimilar based on that reference product."

A Fifth Amendment Argument

While most people know the Fifth Amendment for its right to refrain from self-incriminating speech, among its other provisions is one highly relevant to WLF's argument, that being the right to receive just compensation for property taken for public use.

WLF argues that those provisions clearly apply in this case, but explains that the BPCI's authors neglected to include any funding to compensate biologics companies for the use of their trade secrets. Without such "just compensation," FDA has no other choice but to deny their use in the meantime, the group claimed.

"Any other policy would expose FDA to massive Takings Clause liabilities that Congress has not authorized the agency to incur," it added.

As of October 2012, FDA said it was still formulating a response to similar objections raised by Abbott in its Citizen Petition. It noted that it plans to respond to that petition "as soon as we have reached a decision." No date or estimation was provided by FDA.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles