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masterlongevity

01/06/11 9:49 PM

#112082 RE: DewDiligence #111963

thanks, then this is a HUGE advantage for biosimilars.

I worked on that Rituxan clinical development program and it took a lot of phase 3s, a lot of regulatory meetings, and a lot of work and a lot of money to get all those approvals. I would say ~15 ph 3s were needed in the NHL/CLL space over many years to get the broad label that Rituxan has.