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In Brave New World of Follow-On Biologics, Can't We Do Better Than 1984?

This article was originally published in RPM Report

Executive Summary

Congress has moved into the final horse-trading phase of policy development regarding incentives for innovators and biosimilar product developers. The main question on Capitol Hill is what compromise can generate enough support to survive the political process. Jeffrey MOe, a Duke business school professor with experience developing incentives for drug development policy, suggest Congress should reflect before forging its political decision.

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Long-term Balancing Act: Incentives and FOBs Pathway

As Congress finishes its work on a pathway for follow-on biologics, a number of key decisions affecting incentives for copies and innovative products remain. No matter how the new legislation turns out, a number of issues will remain to be worked out in practice and will dominate investment and drug development policy for decades to come.

Big Pharma May Be Big Player in Follow-On Biologics Market

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.

Orphaning Biotech? The Impact of Biosimilars on Biotech Investment

An abbreviated follow-on biologics pathway is inevitable, despite the fact that Congress failed to pass legislation in 2007. Will a FOBs pathway adversely impact money flowing into the biotech industry? Unlikely. The impact of the 1983 Orphan Drug Act may be a good model to consider.

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