Replies to post #142551 on Biotech Values

[DewDiligence]

To enable a single global FoB program for Herceptin, PFE would like to show that there is no difference of consequence between Herceptin made in Europe and Herceptin made in the US.

One of the points of contention between drugmakers and regulators has been the requirement in the current FoB guidelines that the reference drug for an FoB be locally sourced. This issue was prominently addressed at the FDA public hearing on FoB’s last week (#msg-75552370); it is, IMO, one of the areas in which changes to the guidelines are likely.

[mcbio]

In this study, healthy male volunteers will receive a single intravenous administration of either PF-05280014 or trastuzumab (United States) or trastuzumab (European Union)

If I were a patient, I would demand trastuzumab U.S. Would have concerns over stability of trastuzumab EU.