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DewDiligence

05/02/12 9:25 AM

#141159 RE: DewDiligence #140273

ABT asks FDA to not approve Humira FoB’s because ABT says companies who rely on information in ABT’s Humira BLA would violate the company’s trade secrets:

http://www.fiercepharma.com/story/abbott-tries-throw-roadblock-humira-biosim/2012-05-01

I give this argument close to a nil chance of prevailing with the FDA. If the FDA agreed with ABT, it would be tantamount to putting the FDA’s FoB pathway on hold since only biologics approved after the enactment of ObamaCare would be exposed to the use of “proprietary” BLA information by would-be FoB competitors.