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Re: DewDiligence post# 111957

Wednesday, 01/05/2011 9:06:02 PM

Wednesday, January 05, 2011 9:06:02 PM

Post# of 257261
Rituxan has several NHL indications in the label.

Front-line agressive
Relasped Refractory indolent
Frontline Indolent
Maintenance
Etc....


For a biosimilar, will it also need ph 3 trials in each of the NHL subindications to get approval in those area?

This is specific to Rituxan, but i have that general question about biosimilars?

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