Biotech drugs: Preserve incentives for investment in these drugs








To preserve existing incentives for investment and innovation, the Pathway for Biosimilars Act provides a data exclusivity period equivalent to patent protections for small molecules. The Congressional Budget Office has determined that 11.5 years is the average length of time that drugs are marketed under patent. In other words, innovative drugs and biologics typically stay on the market for about 12 years before facing competition.

My legislation proposes allowing competitors access to this data and a shortcut into the market, but also preserves the existing incentives for innovators by maintaining a 12-year period of concurrent data protection as a “backstop” to existing patent protections. The bill also sets forth a process to resolve all patent litigation prior to launch of biosimilars, providing the opportunity to resolve important intellectual property issues and certainty to all parties without market disruptions. Unlike any other proposal, my bill also provides an opportunity for third parties, such as universities and medical centers, to protect their rights.

I've been joined by a diverse group of more than 100 bipartisan cosponsors in the House of Representatives. Our bill is the only legislation endorsed by the Association of American Universities, the National Venture Capital Association, the Biotechnology Industry Organization, the governors of 4 states and a wide array of patient and industry groups.

The time has come to provide a regulatory pathway for safe and cheaper versions of the biologics that save thousands of lives and improve the quality of life for countless more.

Eshoo, a Democrat, is a member of the House Committee on Energy and Commerce. She represents the 14th Congressional District, which includes San Mateo, Santa Clara and Santa Cruz counties.