BIO Statement calls AARP biologics study flawed.
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Press Release Summary:
Regarding a study on biosimilars presented to Congressional staff by the AARP, Biotechnology Industry Organization (BIO) issued a statement calling it "simplistic, misleading and extremely flawed." The statement goes on to say the study "is based on fuzzy math and even fuzzier assumptions" and that it "cherry picks the best selling biologic products to draw erroneous conclusions, ignoring the bulk of the biologics market."
Original Press Release:
AARP Biologics Study Based on Fuzzy Math, Flawed Assumptions
WASHINGTON, D.C. (Thursday, June 11, 2009) - The following statement was issued by the Biotechnology Industry Organization (BIO) regarding a study on biosimilars presented to Congressional staff today by the AARP:
"The so-called AARP 'study' is simplistic, misleading and extremely flawed. It is based on fuzzy math and even fuzzier assumptions.
"The study cherry picks the best selling biologic products to draw erroneous conclusions, ignoring the bulk of the biologics market. The real facts show that only a small percentage of biotechnology products have the types of financial returns identified in the AARP study. If AARP had analyzed all of the more than 200 other FDA-approved biologics they conveniently left out of their fact sheet, their analysis would have reached a much different, and more credible, result. That's because the 'break even' point for all the other FDA-approved biologics approaches 50 years.
"Greater than 90% of biologic products fail before even getting to clinical trials. Of those entering clinical trials, only 30% get approved by FDA. Of those approved products, only 34% generate profits equal to or greater than the development cost over the product's lifecycle.
"As one of the nation's largest insurance providers, AARP has a lot to gain financially by using its considerable lobbying muscle to push Congress to pass biosimilars legislation that will benefit insurers by providing short-term cost savings at the risk of jeopardizing the continued development of advanced and breakthrough medicines and cures for patients. Biotechnology medicines extend and improve the quality of life - and provide renewed hope - for patients suffering from debilitating diseases such as cancer, HIV/AIDS, Parkinson's, Multiple Sclerosis, diabetes and a host of rare diseases.
"Congress should not develop public policy based on such a flawed and blatantly biased analysis. Now is the time to implement a pathway to 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."
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July 19-22, 2009
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October 30, 2009
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November 2-4, 2009
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About BIO
BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world's largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.
