FDA Denies Abbott Petition Seeking Humira Biosimilar Block
In approving an Amgen biosimilar for the first copy of Abbott’s Humira (adalimumab) for multiple inflammatory diseases (see story), FDA also simultaneously denied an Abbott petition that sought to block the action by arguing such approval would violate the U.S. Constitution’s Takings Clause. The petition argued that an FDA finding that a potential biosimilar product is “highly similar” to the innovator product is a violation of protected trade secret information provided to the agency in good faith.
Abbott said that when it submitted its trade secret information in 2002 it had no notice or reasonable expectation that FDA would use it to approve another company’s product. “Under well-established Supreme Court jurisprudence, FDA’s use of the trade secrets in pre-enactment sponsor’s BLAs to support approval of competitor products would frustrate these sponsors’ investment-backed expectation regarding their property and would constitute a taking under the Fifth Amendment to the U.S. Constitution that requires just compensation,” it said. The ill-fated petition further contended that FDA should not implement the Biologics Price Competition and Innovation Act in a way that would raise this constitutional issue.
In a 9/23 denial letter, FDA said the Fifth Amendment does not protect information that Abbott described as trade secrets but that was available for public disclosure under the agency’s information disclosure regulations after the Humira BLA was approved in 2002. “Such publicly available information cannot satisfy the second element under the UTSA definition of a trade secret, i.e., that the information ‘is the subject of efforts that are reasonable under the circumstances to maintain its secrecy,’” the agency said. “Under FDA’s regulations, FDA must make ‘[a]ll safety and effectiveness data and information’ submitted in a BLA ‘immediately available for public disclosure unless extraordinary circumstances are shown’ following approval of a BLA. The phrase safety and effectiveness data includes ‘all studies and tests of a biological product on animals and humans and all studies and tests on the drug for identity, stability, purity, potency, and bioavailability.’”