Replies to post #59068 on Biotech Values

[sodrock]

“We believe that MNTA’s technology will enable us
to uniquely demonstrate equivalence to innovative
products. Out intent is to develop FoB’s that are
not simply biosimilar but have the potential to be
biogenerics, interchangeable and substitutable
for the branded biologics.”
—Craig Wheeler, CEO (from 2/14/08 CC)

I just had to re-post this for all to see. They accomplished this in a BIG way with Menox... SNY was totally baffled that they were able to get FDA approval for Menox as an interchangeable product. Again this is so key as to why TEVA is dead in the water with their version.. So very very important.

[mcbio]

“We believe that MNTA’s technology will enable us
to uniquely demonstrate equivalence to innovative
products. Out intent is to develop FoB’s that are
not simply biosimilar but have the potential to be
biogenerics, interchangeable and substitutable
for the branded biologics.”

—Craig Wheeler, CEO (from 2/14/08 CC)

Is it your expectation that MNTA may be the only company with the technology to pursue fully-substitutable biogenerics? I think you said that MRK is already pursuing the traditional pathway; I assume they don't have the expectations to be able to produce fully-substitutable biogenerics.

If this is the case, and MNTA does show down the road that they are the only company to produce fully-substitutable biogenerics, I assume this will be a huge advantage for MNTA and whomever their partner ends up being. Is that your expectation in such a scenario or do you think the companies simply focused on biosimilars will still be able to successfully compete with fully-substitutable biogenerics on, say, pricing? E.g., I assume a biosimilar would be priced lower than a fully-substitutable biogeneric, which might allow them to successfully compete. Can't recall if we've discussed all of this before.

[DewDiligence]

I question the premise of this Reportlinker research report on FoB’s:

http://finance.yahoo.com/news/biosimilars-emerging-economies-advanced-recombinant-105800680.html

Low Cost Manufacturing Put India and China at a Strategic Advantage in Biosimilar Production

Probably true for FoB’s that are non-interchangeable with their branded counterparts. For interchangeable FoB’s, on the other hand, rock-bottom manufacturing cost would seem to be less important than the ease of establishing sameness to the FDA’s satisfaction.

p.s. Teva’s low-cost effort at producing generic Lovenox hasn’t worked out well.