NutritionFTC Report On Biosimilars Is Fundamentally Flawed
The following statement was issued by Jeff Joseph, Biotechnology Industry Organization (BIO) Vice President of Communications, in response to a new report on biosimilars released today by the Federal Trade Commission (FTC):
"We received earlier today a copy of this lengthy FTC report and will review it closely.
"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. The report appears to minimize greatly the impact on innovation that would occur under a new paradigm in which biosimilar competitors would be able to take a free ride off the massive R&D investment made by the initial innovators.
"Two thirds of the future clinical pipeline for patients resides in small biotech companies -- companies without profits, companies heavily reliant on private investment to fuel R&D, companies that are particularly susceptible to negative changes in investment incentives.
"Biotechnology medicines extend and improve the quality of life - and provide renewed hope - for patients suffering from debilitating and life-threatening diseases for which there currently are no or inadequate therapies such as cancer, HIV/AIDS, Parkinson"s, Multiple Sclerosis, diabetes and a host of rare diseases. Biotechnology also creates high-wage, high-value jobs and has a high multiplier effect: the 1.3 million Americans employed in the biosciences in 2006 (the latest year for which data is currently available), helped to create an additional 6.2 million jobs, for business services, contractors and other vendors. An unbalanced pathway to biosimilars jeopardizes the ability of biotechnology to continue U.S. leadership in innovation, provide hope for patients and help drive economic growth.
"While the FTC does not have policymaking authority in this area, the Congress does. We urge the Congress to take a more balanced approach to biosimilars policy. We continue to support a regulatory pathway for biosimilars that safely increases access to the breakthrough therapies and cures for the patients of today while preserving the incentives necessary to address the unmet medical needs of the patients of tomorrow."
BIO"s rebuttal to specfic findings in the FTC report is available here.
BIO