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pcrutch

08/25/10 9:20 AM

#102419 RE: DewDiligence #102418

If you have a better summary, then feel free to correct me. I don't claim to be perfect or know everything about MNTA. I will correct it.
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Robert C Jonson

08/25/10 5:59 PM

#102494 RE: DewDiligence #102418


Dew, do you agree with the following opinion? If so, it seems to me that companies interested in doing biosimilars would be following SNY's court case closely.

http://abcnews.go.com/Business/wireStory?id=11239476

Lovenox is technically not a biologic drug — a complex medicine made inside special, live cells rather than by combining chemicals. However, "functionally and effectively it is," Anderson wrote, because it is derived from animal materials and is heavily processed and purified.

The FDA's decision to make Momenta's drug fully "substitutable" for Lovenox, according to Anderson, "might signal what FDA may also ultimately do when it comes to 'true' biologics that generic companies are also pursuing."