QDIS Blog

Here is a recent article in the Boston Globe. They report that European regulators testified to a congressional panel that some biological products can fairly easily be produced such as insulin and human growth hormone. Others are too complicated to be safely duplicated.

Caution urged on biologic drugs - The Boston Globe

Europe has had biogenerics for the last four years but European regulators have required human clinical trials for these products. I think there is need for talking about what process may be in the best interest of patients and is safe. I’d like to see criteria developed for biologics that would allow it to be determined which can be safely approved in a fashion similar to the current generics model based on bioequivalence, and which would have to undergo human trials. I don’t fall into the trap that some do of insisting it is either one or the other. However I think it may be difficult to draw up guidelines for determining which track a given product should follow that a majority will agree with. That doesn’t mean it can’t happen, but it will be contentious.

Technorati Tags: biogenerics, FDA

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