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Generics For Biologics

Federal Trade Commission favors earlier generic competition for protein drugs

by Glenn Hess
June 22, 2009 | A version of this story appeared in Volume 87, Issue 25

The Federal Trade Commission (FTC) says it supports giving FDA explicit authority to approve generic versions of expensive biologic drugs as a way to lower consumers' health care costs.

In a lengthy report on the outlook for biologic drug competition, FTC says that "Follow-on biologics, if brought to market, could reduce the estimated $40.3 billion a year consumers spend on biologic drugs."

Unlike small-molecule medicines made by chemical synthesis, biologic drugs are proteins derived from living organisms and are among the most expensive and complicated on the market. Competing bills have been introduced in Congress to establish a regulatory pathway to bring lower cost generic biologics, also known as follow-on biologics or biosimilars, to market (C&EN, April 6, page 23).

Biotech firms such as Genentech and Amgen argue that, in order to recoup the cost of discovering and developing original biologic drugs, they need up to 14 years to market their medicines without competition from cheaper generic versions. The generics industry has proposed letting companies duplicate biologics after five years.

FTC appears to favor the shorter period, saying the 12 to 14 years of exclusive marketing sought by the makers of brand-name biologics is "too long to promote innovation," partly because "they likely will retain substantial market share" even after competition begins.

The Biotechnology Industry Organization says FTC's "fundamentally flawed" conclusions greatly minimize the impact on innovation that would occur if generics manufacturers were able to "take a free ride off the massive R&D investment made by the initial innovators."


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