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Wednesday, July 8, 2009
Biotech council: Biologics, innovation need protection from generics
MHT's Marc Songini: Mass. bio firms prep for lifting of stem cell ban
Flash Slideshow: Mass High Tech All-Stars Thought Leadership Roundtable
President Obama and Congressional leaders have made a clear case for reform on the U.S. health care system, and we fully support a reform that would improve quality of care and controlling costs.
President Obama and draft proposals in Congress have provided us with hope in these uncertain times, and we appreciate the strong initiative he and congressional leaders have demonstrated in attempting to reach consensus expeditiously. Members of the biotechnology industry — from early-stage startup companies to global biotech leaders — have significant concerns about one particular aspect of the health care reform effort, a pathway to biosimilars. Our industry has long advocated for a pathway based on sound science, transparency and patient safety. A critical component of the biosimilars pathway is sufficient period of innovator exclusivity to promote the next cycle of innovation and discovery in life sciences.
We have committed to working with our delegation, led by U.S. Sen. Edward Kennedy in the Senate and U.S. Rep. Michael Capuano in the House, to ensure patient access to safe and affordable medicines, while protecting and sustaining continued biomedical innovation. The future of biotechnology and continued medical breakthrough rests with ensuring that any biosimilars pathway protects and promotes both innovation and the best interests of patients.
Biologics are complex medicines manufactured using living organisms. Many of the latest breakthrough medical therapies for serious illnesses such as cancer, multiple sclerosis, diabetes, HIV/AIDS, and a number of life-threatening rare diseases are biologics. They are different and far more complex than most small-molecule drugs, and they cannot be reproduced exactly using existing science. Any regulatory pathway must recognize that an approved follow-on biologic would not be a generic drug, because a follow-on biologic may be similar to, but not the same as, the innovator product.
Because medical innovation is both risky and expensive, Congress must allow the developers of biologic medicines to protect for at least 12 years the proprietary data used to create the original medicine. This period of 12 years is needed to maintain U.S. competitiveness and leadership in the development of new biologic medicines in this rapidly changing global environment. After that period, the FDA can rely on the innovator’s data to approve a competitor’s product. A similar process and timeline exists for the development of generic versions of traditional medicines, such as cholesterol-lowering drugs.
In addition, biosimilars legislation must include a balanced procedure for the resolution of patent-related disputes that may occur with respect to biosimilars, so such disputes can be resolved prior to the market-entry of a biosimilar, thus protecting the intellectual property rights of innovators and other third parties, such as academic institutions that often are the inventors of new technologies.
We understand the pressure of ever-increasing health care costs on businesses and those families dealing with a serious illness, particularly in today’s difficult economic times. We are committed to working with all to develop a system that makes health care, including biologics, more affordable to patients, while nurturing our globally competitive life sciences sector in Massachusetts and across the United States.
Massachusetts is a global force in discovering new cures for diseases, bringing hope to millions of people suffering from unmet medical needs. Massachusetts’ biotech cluster has become a dynamic economic engine that attracts new investment, construction, research, business and thousands of new jobs. Research shows:
• The biotechnology industry employs nearly 45,000 people in Massachusetts, generating $3.9 billion in payroll.
• The biotechnology industry grew more than 30 percent between 2002 and 2006, while statewide employment grew less than 1 percent.
• More than 10 percent of the global biotechnology drug development pipeline is based in Massachusetts.
• The life sciences industry generated $7.6 billion in exports from Massachusetts in 2008, or 27 percent of all Massachusetts exports.
• Massachusetts-based biologic and pharmaceutical drug manufacturers generated $9.5 billion in sales in 2007.
• Massachusetts is a model for other states in developing similar clusters of biotechnology excellence across the country.
We need to ensure that Massachusetts and the nation remain at the forefront of this breathtaking new era of discovery in the life sciences. Our industry’s success is dependent on continued innovation and a strong record of patient safety. But this simply won’t be possible if Congress creates a pathway for biosimilars — including exciting new therapies emanating from embryonic stem cell research — that erodes patient-safety protections or fails to secure adequate incentives for innovation.
Robert K. Coughlin is president and CEO of the Massachusetts Biotechnology Council.
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