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Thursday, June 16, 2011 7:47:11 PM
Based on DEW's survey results 2015 is the date for 1st biogeneric and for MNTA it appears biogeneric makes sense ...prolly MNTA could lead on the biogeneric front.
I am almost ruling out possibility of MNTA filing biosimilar application or partnering on biosimilar. So no FOB launch for MNTA at least until 2015 (if you go by wheeler's GS call it would be more like 2016) . What to do people think on MNTA's willingness and/or partner's willingness to partner on "biosimilar" (I feel it is low)
wheeler has said biogeneric(substitutability is huge). biosimilar may not gain much market share(remains to be seen)
because MNTA's expertise is in proving sameness,
of-course there might be clinical trial requirement for both biosimilar and biogeneric...although one would think trial requirements for biogeneric maybe more?
any other company would be able to file biosimilar (without stringent sameness requirement as required in biogeneric) as they may already have clinical data package from elsewhere, for example from europe
Based on this, the Hospiras of the world would prolly launch the 1st biosimilar say in 2013
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