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BIO reacts to FTC biosimilars report


WASHINGTON Despite drawing praise from the generic drug industry, a report on biosimilars released Wednesday by the Federal Trade Commission didn’t get such a warm welcome from the biotechnology industry.

 The Biotechnology Industry Organization called the report “fundamentally flawed,” saying that it “places short-term cost considerations ahead of continued biomedical innovation for patients” in a response released late Wednesday afternoon. The organization said it would have a more detailed analysis Thursday.

“Upon first glance, it appears that the summary conclusions in the report are based upon fundamentally flawed or highly selective assumptions, an exceedingly narrow policy perspective and a lack of true understanding of the necessary conditions to drive future biomedical breakthroughs,” BIO VP communications Jeff Joseph stated.

According to the report, allowing a regulatory pathway for biosimilars would be an “efficient” way to bring them to market and lower consumers’ healthcare costs, but it wouldn’t result in the sort of dramatic competitive environment that exists between branded and generic pharmaceutical drugs. The report also said that the market exclusivity period of up to 14 years favored by BIO is “too long to promote innovation.”

The generic drug industry, represented by the Generic Pharmaceutical Association, prefers a five-year exclusivity period, similar to the one provided by the Hatch-Waxman Act of 1984.

By contrast, the GPhA welcomed the report.

“We can no longer have a healthcare system where patients only have access to expensive brand biologic medcines, which some expect to comprise half of all the new medicines approved by FDA in 2012,” GPhA president and CEO Kathleen Jaeger said. “The price of these drugs continues to soar, placing them out of reach to countless Americans.”

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