Maryland Community Newspapers Online
The recent opening of the Shady Grove Life Sciences Park in Rockville provides another sign that Montgomery County is ready to become what some already call a "biotech version of Silicon Valley." The county where researchers helped decode the human genome is already home to more than 200 biotechnology companies, including many that make high-tech medicines called biologics.
Last year, biotech in the county generated combined revenues of $2.36 billion, according to the county's department of economic development, and employed more than 58,000 workers in private and public sectors. Yet the great promise of medical biotech for patients and for the Maryland economy is threatened by a little-noticed provision of health care reform: a provision that outlines the means for companies to sell similar versions of innovative biologics, called "biosimilars." In attempting to create a pathway for biosimilars, Congress must be careful not to kill the innovation behind the development of original new drugs.
Biologics are on the cutting edge of medical progress. If we are to find cures for cancers, Alzheimer's, diabetes and other diseases that have confounded researchers for decades, it is projected that biologics will play an ever-increasing starring role.
We support Congress' plans to create a regulatory pathway for companies to sell similar versions of an original biologic that protects patient safety and incentivizes innovation. But innovators spend 10 to 15 years and $1.2 billion on average to develop a biologic. They must be allowed a reasonable amount of time to sell their product before being forced to share their research with a biosimilar company. Most importantly, legislation should ensure patient safety by requiring biosimilar sponsors to test their products in human clinical trials to demonstrate the product's safety and efficacy prior to approval. It bears repeating that biosimilar products are similar to, not exact duplicates, of previously-approved innovator biologics.
Committees in both the House and Senate have passed, with bipartisan support, amendments that would give innovators 12 years before having to share their data. That is the minimum number suggested by an economic analysis that found that it takes between 12.9 and 16.2 years for an innovator to recoup the return on their investment on an innovative biologic product. This is, after all, a vibrant but fledgling industry in which more than 80 percent of companies have yet to make a profit.
Research into biologics is an economically risky business. Even among medicines that make it to the first stage of clinical trial development, fewer than 20 percent actually make it to the marketplace. Those that emerge from that funnel face more hurdles. For example, among biologics that made it to the marketplace as of the end of 2008, less than one-third had recouped their research and development costs over a six-year period.
If innovators must share any successful research with competitors before a reasonable amount of time has passed, investors are simply not likely to fund more innovative research. Without investors, there are no companies, no jobs, no new medicines.
At stake in Montgomery County is an industry that County Executive Isiah Leggett has called a "cornerstone" of the county's economy, now and in the future. The new biotech center in Rockville is part of a 10-year, $1.1 billion state initiative that Gov. Martin O'Malley has called "a giant step forward in harnessing all the potential that is already within our grasp." The center is intended to support existing biotech companies in the county, attract new ones and coordinate the efforts of academics and companies.
Leggett has urged Maryland's congressional delegation to approve the legislation providing 12 years of data protection, saying it would "allow Maryland to sustain and enhance its leadership in biomedical innovation and discovery."
We urge all of Maryland's representatives in Congress to support the current language providing for a patient safety-based biosimilars pathway that contains 12 years of data protection to encourage continued innovation when this legislation comes to the House and Senate floor as a part of health care reform.
Tony Zook, Gaithersburg
The writer is president of MedImmune, a Gaithersburg biotech company, and is executive vice president of AstraZeneca North America.