Biotech companies, some of which are located in the senator’s home state, prefer the European model: approval requirements that reflect the complexity of a generic biologic, and sometimes extensive testing, which of course, will be very costly to generic drugmakers.

Tomorrow, the Senate health, education, labor and pensions committee, which Kennedy chairs, will hear differing views about the kind of guidance the FDA should provide industry. One of Kennedy’s staffers tells The Boston Globe that following Europe’s example makes sense.

Boston-area biotechs nod in agreement. “The public safety is at stake. The public confidence is at stake. You can’t force the issue. You have to do it carefully,” says Henri Termeer, Genzyme’s ceo. And Biogen Idec spokesman Tim Hunt says that waiving clinical trial requirements is “lowering the bar on drug safety. To achieve safety, you’re probably going to need to run clinical trials.”

Good point. It’s certainly true that more information is always better. But ti’s also true the high price of biologics, which run thousands of dollars a month, reflects not only high development costs, but a lack of competition. There are, after all, very few ‘me-too’ biologics. Tomorrow’s hearing may shed some light on how long it will be before that changes.

[tags]Biogen Idec, Biologics, Generics, Genzyme[/tags]