CHI Submits Statement on Follow-on Biologics Legislation.

LA JOLLA, Calif. -- The following statement was issued by California Healthcare Institute (CHI) President and Chief Executive Officer David Gollaher, Ph.D., regarding legislation introduced today by Rep. Anna Eshoo (D-Palo Alto), Rep. Jay Inslee (D-Wash) and Rep. Joe Barton (R-TX) to establish a pathway for the approval of follow-on biologic drugs, a strong bipartisan measure with support from across the California delegation.

"On behalf of the California Healthcare Institute (CHI), whose more than 250 members include our state's leading biotechnology, medical device and diagnostics companies, venture capital firms and research institutes and universities, I support your legislation to provide for U.S. Food and Drug Administration (FDA) approval of follow-on biologics (FOBs), the 'Pathway for Biosimilars Act.'

"While focused on the development of the next generation of innovative medicines, we understand that the increasing cost of healthcare is a growing burden for private-sector and government budgets. In the long term, competition among biosimilar products is likely to yield savings within the U.S. healthcare system. Considering the complexity of large molecule product development and manufacturing, CHI believes that it is possible to develop a successful, science-based FOBs approval pathway. This pathway must employ the best science to ensure the safety of products for patients, encourage price competition among manufacturers, and provide ample incentives to encourage continued private-sector investment in the next generation of breakthroughs.

"'The Pathway for Biosimilars Act' meets these standards:

1. Clear Guidance: As suggested by the FDA's Chief Scientist in his recent letter to Congress, this legislation requires the FDA to formulate scientific standards for FOBs approval and determination of interchangeability through a flexible, clear, and public guidance process;

2. Clinical Trials and Safety: Ensures that no follow-on product is approved without appropriate and careful scientific demonstration, including the assessment of immunogenicity, that the product is 'biosimilar' to the approved reference biological product;

3. Patent Dispute Resolution: Establishes an equitable framework for exchanging information among innovator manufacturers, biosimilar manufacturers and third-party patent holders, such as universities and private research institutes whose scientific breakthroughs are licensed to the private sector for commercial development.

4. Innovation: Encourages future investment in biopharmaceutical research and development by providing at least 12 years of data exclusivity before the FDA can reference the expensive and time-consuming safety and efficacy testing conducted by an innovator in order to approve a follow-on product. This critical element both recognizes that follow-on manufacturers, developing products that are 'similar' to innovators' products, may work around innovators' patents. The protection of clinical trials data is thus far more important for biologics than for traditional chemical pharmaceuticals; we believe that 12 years of protection will produce outcomes for biotechnology companies similar to those currently in place for traditional pharmaceuticals under the Hatch-Waxman bill of 1984.

"Biologic drugs represent the forefront of medical research and the biomedical industry in California has developed advanced therapies and treatments for patients based on this technology. Continued investment in research and development will lead to safer, more effective and efficient, personalized treatments, and cures, for diseases such as Alzheimer's, cancer, diabetes and HIV/AIDS.

"Our industry, which employs more than 270,000 people in California in high-wage, high-value jobs, is a vital aspect to California's economic future. Because our work depends on large and risky investments to support drug development that typically requires 12 to 15 years to reach the market, we are vulnerable to policies that do not reward innovation.

"We congratulate Reps. Eshoo, Inslee and Barton for understanding the nature of research and development and proposing a responsible, science-based pathway for approving follow-on biologics that safeguards patient safety and provides incentives to continue research and development of novel treatments and cures."

About California Healthcare Institute

CHI represents more than 250 leading biotechnology, medical device, diagnostics, and pharmaceutical companies, and public and private academic biomedical research organizations. CHI's mission is to advance responsible public policies that foster medical innovation and promote scientific discovery. CHI's Web site is www.chi.org.