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Biogenerics Are Coming and They're Not the Generics We Know

Executive Summary

Biotech and would-be biogenerics companies are battling to shape the future of generic biologics. The FDA, along with established biotech and drug companies, has opposed the concept of biogenerics, insisting the compounds are too complex to be reproducible in a reliable fashion. Challengers insist that the science is advanced enough to make such products feasible and are pumping significant time and money into bringing them to market.

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This article is a reprint from the April 2008 issue of The RPM Report. As Congress works on an approval pathway for follow-on biologics, generic drug companies are jockeying for investors' attention. But given that most generic manufacturers may be ill-equipped to handle the development of follow-on proteins, some analysts think the real opportunity is where you'd least expect: inside Big Pharma and biotech.

FDA Hesitates on Biogenerics

A long-awaited Food and Drug Administration (FDA) workshop held in mid-September, highlighted just how far the agency is from establishing a regulatory path for generic copies of biologics. Although it yielded few surprises, the meeting provided a concentrated public forum for interested parties to present in-depth views of all sides of the issue--an unusual event in itself

FDA Hesitates on Biogenerics

A long-awaited Food and Drug Administration (FDA) workshop held in mid-September, highlighted just how far the agency is from establishing a regulatory path for generic copies of biologics. Although it yielded few surprises, the meeting provided a concentrated public forum for interested parties to present in-depth views of all sides of the issue--an unusual event in itself

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