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DewDiligence

05/10/11 2:05 PM

#119752 RE: jbog #119750

I'm wondering how they would treat something like Lilly's humanized egfr versus the chimeric cetuximab?

They will be considered different drugs, IMO.
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biotech jim

05/10/11 2:52 PM

#119757 RE: jbog #119750

Neupogen vs the longer half-life Neulasta would be a good example of this (but prob would be considered a different drug than a biobetter?). Neulasta has a protein modification for plasma stability, thus making a longer lasting t1/2. Modest bone pain comes from the more chronic stimulation, and aspirin or acetominophen can alleviate that. Due to excessive stimulation, one can have spleen effects but the label on Neupogen indicated spleen rupture in the early chronic sq injection trials.