Follow On Biologics Loses Momenta

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  • 11/07/2007
Those screams you heard came from "I hate Big Pharma" being hoisted on the drug safety petard of their own making as Momenta's hard to mimic version of Lovenox was being rejected by the FDA because of concerns that the company hadn't accounted for uncountrolled immune reactions to its version of the product. And of course that doesn't even begin to to address what sort of studies Momenta would have to undertake to deal with safety concerns, what risk mitigation system it would have to put in place, what post marketing surveillance it would have to conduct, what clinical trials data it would have to post, blah,blah blah.

FOBs will hit the market eventually. But it is great to see those who take drug companies to task about safety seek to rationalize rushing FOBs to market without similar consumer protections. And they care more about rushing FOBs to market than accelerating the review of new life saving medicines which Momemta is also working on. It's called I hate pharma hypocrisy.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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