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jbog

06/16/11 9:49 AM

#3843 RE: sodrock #3841

Sodrock

Regardless of expense the FDA is not going compromise safety and create an even more expensive burden on the system.



The FDA wouldn't compromise safety because all the biosimilars would follow the somewhat limited clinical trial path that the EU is following. What I'm saying is that once an biosimilar becomes approved, the FDA or HHS would make it substitutable.