BIO Testifies on Importance of Data Exclusivity and Patent Protection in Pathway for Approval of Biosimilars

WASHINGTON, D.C. (Wednesday, July 15, 2009) - The Biotechnology Industry Organization (BIO) testified yesterday before the House Judiciary Subcommittee on Courts and Competition Policy on “Biologics and Biosimilars: Balancing Incentives for Innovation.”

“We thank the Subcommittee for holding a hearing on the critical topic of balancing incentives for innovation in a biosimilars pathway.   BIO continues to strongly support a pathway for the approval of biosimilars which protects patient safety and preserves incentives for continued innovation,” BIO President and CEO Jim Greenwood stated. “We look forward to continuing discussions in the House and Senate as they consider this issue in the context of health care reform.”
In his testimony on behalf of BIO, Jeffrey P. Kushan of Sidley Austin LLP stressed the importance of including significant data exclusivity in any pathway for the approval of biosimilars and the need to provide a fair and balanced system to resolve patent disputes before a biosimilar is approved and marketed.

“By allowing the biosimilar manufacturer to ‘free-ride’ on the clinical data of the innovator, the abbreviated pathway helps the biosimilar manufacturer bring its product to market faster, with far less risk and uncertainty, and at a fraction of the innovator’s development costs. Unquestionably, the business of biotechnology innovation will change once an abbreviated pathway for biosimilar products becomes available,” stated Kushan.  “And patent rights, as they exist in today’s system, simply will not be sufficient to preserve the incentives for development of new biological products and treatments that exist in today’s industry.”

“Measures that offset the impact of these fundamental changes to the nature of competition in today’s biotechnology industry must be integrated into any new regulatory approval system for biosimilar products,” Kushan stressed.  “Measures that operate to lessen the economic incentives of our current system will translate into fewer new biological products and therapies, to the detriment of patients with currently unmet medical needs.”

Kushan also rebutted the recent report by the Federal Trade Commission (FTC) by pointing out that the report’s conclusions are not supported by evidence.  He explained how the FTC incorrectly portrayed the nature and effects of competition between biosimilar and innovator companies, incorrectly described the capacity of patent rights alone to encourage initial and ongoing clinical research in a biosimilar market, and incorrectly asserted that data exclusivity under Hatch-Waxman is provided only for unpatentable drugs.

BIO’s testimony is available at

Upcoming BIO Events

World Congress on Industrial Biotechnology & Bioprocessing
July 19-22, 2009
Montreal, Quebec, Canada 

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 

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.