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S. 1695, The Biologics Price Competition and Innovation Act of 2007 (2 comments ↓)

S. 1695 would amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and it would promote innovation in the life sciences.

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Ryan

One of the reasons why generic drugs are good for the consumer is that the companies don't have to do clinical trials. There are already methods of characterization which are acceptable for showing biological equivalence. By forcing follow-on biologic producers to do clinical trials (which they don't have to do for chemical, small-molecule drugs), this will increase cost to the consumer and reduce the level of treatment available to those who need it most.

m

Clinical trials are necessary for biosimilars though because regular generics (small molecules) have no risk of triggering an immune system reaction. The science is different for the two types of generics and thus clinical requirements are different

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