Europe is years ahead of the united states in paving the way for what it calls “biosimilars.” The european union passed legislation in 2003 that establishes a regulatory pathway for abbreviated approval of follow-on biologics. The E.u. framework requires applicants to conduct specific comparability studies to prove similarity, and to produce preclinical and clinical data to establish safety and efficacy.

But U.S. generic companies don’t want to use the E.U. as a model. they insist that the E.U.’s approval process is too onerous and that safety can be achieved with less. “We have to ensure that in the U.S. the pathway is truly abbreviated,” says Bruce Downey, CEO of generic maker Barr Pharmaceuticals, who is actively promoting the cause of generics in Washington

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