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masterlongevity

01/05/11 9:06 PM

#111960 RE: DewDiligence #111957

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?