[Ip-health] question on EMA and follow on biologics

Vaughan, William WVaughan at consumer.org
Tue Oct 26 09:02:43 PDT 2010

Nov. 2 and 3, the US FDA is holding hearings on how to implement the new health reform law's (PPACA) provision on follow-on biologics....generic biologics. As you know, the US has approved almost no generic biologics.

As an advocacy staffer for Consumers Union (publisher of Consumer Reports magazine), we are testifying on a number of points. I wonder, however, if anyone on the list service has experience with the EMA's approval of what we understand are several dozen generic biologics, whether such approvals have had any safety issues, and whether the entry of multiple generics has made any difference in pricing issues (I know that it may be hard to see that in an administered price system), and in general, pros or cons of the European generic biologics scene.

Thank you for any insights, references, etc.

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