BIO Urges Administration and Congressional Leaders to Reject GPhA’s Request to Turn Their Backs on Hope for Patients and Consumers
"GPhA’s request to the Administration is a cruel trick to the millions of patients who are awaiting the benefits of biosimilars. GPhA is asking the Obama Administration to hold patients and consumers hostage unless it gets its way on this critical provision of health care reform. It’s not surprising that GPhA is asking for delay given this is exactly what they did in 2007 after the Senate Health, Education, Labor and Pensions Committee (HELP) Committee passed a similar proposal, unanimously. What is surprising is how brazen this powerful lobby is acting today. The innovator biotechnology industry actively supports efforts to expand competition in our sector through our strong support of the bipartisan Committee-passed regulatory pathway for biosimilars.
“Biosimilars, often erroneously referred to as ‘generic biologics’, can bring the benefits of expanded competition to biologics, breakthrough medicines that are extending and saving the lives of patients living with diseases such as cancer, diabetes, Parkinson's and Alzheimer's. Well-crafted legislation, such as the language passed out of the HELP and the House Energy and Commerce Committees, lays out an approval pathway for biosimilars that protects patient safety, lowers prices, expands access and provides the incentives necessary to develop new breakthroughs and, one day, cures. This language is supported by more than 150 organizations representing patients, physicians, universities, venture capitalists, labor unions, local chambers of commerce and innovators. This approach also is supported by the governors of 11 states. These disparate interests recognize that a base 12 years of data exclusivity, as provided in the House and Senate language, is critical to ensure the development of the next generation of therapies for patients, lower costs for consumers, and continued job creation within the biotech industry.
“GPhA continues to bend the truth about biosimilars and the language passed in the House and Senate Committees. Despite GPhA’s misleading claims to the contrary, the biosimilars provisions regarding the original product explicitly prohibit any extension to the 12-year exclusivity provision as a result of any change to the product, minor or major.
“Providing a company with data exclusivity does not give it or extend any sort of monopoly. Products that compete with innovative biologics can still be introduced during the period of data exclusivity. They just cannot piggyback off of the research conducted by the innovator company. They must conduct their own safety and efficacy research and testing to obtain FDA approval and, obviously, not infringe the patents of the pioneering company.
“The biotech industry is – at its heart – competitive. The biotech industry currently exhibits robust competition as innovators compete against other innovators, with similar products targeting similar diseases or conditions. In fact, a recent report highlights the rigor of this competition, noting that first-in-class biologics now face competition in just two years.
“Biotechnology provides the best hope for reducing the incidence of terrible diseases such as cancer, ALS and cystic fibrosis. Today’s biologics have turned diseases that were once death sentences into manageable conditions. Tomorrow’s biotech innovations have the potential to do more. Creating a pathway for biosimilars that includes 12 years of data exclusivity will help the biotech industry realize this potential, to the benefit of millions of patients worldwide. Congress should act now to establish a balanced, pro-patient pathway to biosimilars.”
Upcoming BIO Events
BIO Intellectual Property Counsels Fall Conference and Committee Meeting
October 26-28, 2009
Washington, DC
BIO Investor Forum
October 28-29, 2009
San Francisco, CA
Advanced Business Development Course
October 30, 2009
Vienna, Austria
BIO Europe International Partnering Conference
November 2-4, 2009
Vienna, Austria
Pacific Rim Summit on Industrial Biotechnology and Bioenergy
November 8-11, 2009
Honolulu, HI
BIO Asia Partnering Conference
January 25-26, 2010
Tokyo, Japan
February 8-9, 2010
New York, NY
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.
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