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Avoiding No Man's Land: New Deloitte Study on Follow-on Biologics Investigates Proposed Legislation and Possible Unintended Consequences
Date:4/14/2009

SAN FRANCISCO, April 14 /PRNewswire/ -- Deloitte today released a study, Avoiding no man's land: Potential unintended consequences of follow-on biologics, that explores the debate on creating a regulatory pathway for the approval of follow-on biologics (FOBs), drugs that are envisioned as the biotech equivalent of generic pharmaceuticals. The study examines two bills that have recently been introduced in Congress, both based on the model of the Hatch-Waxman Act of 1984. The Deloitte study also outlines unintended effects of the Hatch-Waxman legislation and explores how this experience may help guide current legislation.

"At the crux of the argument is how opening a regulatory pathway for FOBs can be accomplished while maintaining patient safety, and without destroying the incentives necessary to attract investment into the next generation of breakthroughs," said Jim Hollingshead, Principal, Deloitte Consulting LLP, in their Health Sciences practice, who lead the study.

Pharma industry of 1984 vs. biotech industry of 2009

The study notes that basic differences between the pharma industry in 1984 and the biotech industry in 2009 make it difficult to apply Hatch-Waxman as a model for FOBs legislation. According to the study, after 1984, pharma innovators earned sufficient returns to continue drug innovation, while generic producers enjoyed increasing volume growth and market penetration. This was accomplished because patents protected innovators' intellectual property, and the data exclusivity period rarely came into effect.

"In 1984, when the Hatch-Waxman generic drug legislation was enacted, the pharma industry was stable and mature and the legislation provided a catalyst for investment and competition," said Hollingshead. "Today the biotech industry is relatively young and complex not only in its science, but in its financial underpinnings, and is highly reliant on risk capita
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SOURCE Deloitte
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