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DewDiligence

02/10/09 12:36 PM

#18023 RE: gdgray #18019

Re: LFB’s CD20 programs (plural)

Dew, do you think that the MAbgene program might not be the shinning star hoped for and that GTC's program is insurance?

I did not know about LFB’s in-house (non-GTC) CD20 program until today because GTC has never disclosed the existence of such a program. Hence, I can only speculate about what LFB is attempting to do.

My guess is that the CD20 drug manufactured by MAbgene is intended to be a Rituxan biosimilar that can be approved in the EU fairly quickly using an abbreviated clinical program that relies in part on the Rituxan dossier.

The LFB-GTC CD20 compound, on the other hand, targets a different epitope than Rituxan and hence is suited to being a “biobetter” rather than a biosimilar. The LFB-GTC compound will probably require a full-fledged clinical program that does not rely on the Rituxan dossier.