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DewDiligence

12/22/11 10:45 AM

#133580 RE: Biowatch #133579

Without biosimilar approval framework, patent exp. dates meaningless in many cases.

I do not understand what you mean. Companies are already inking FoB partnerships and have been meeting with the FDA to get guidance on FoB clinical-trial designs. The guidance documents that the FDA eventually publishes will codify and possibly expand on what the FDA is already telling companies during these meetings.