(LA JOLLA, Calif., Friday, July 31, 2009)–CHI-California Healthcare Institute released the following statement todayon the approval of language to create a regulatory pathway for U.S. Food and Drug Administration (FDA) approval of biosimilars, or follow-on biologics, by the House Energy and Commerce Committee in today’s mark-up of the America’s Affordable Health Choices Act (H.R. 3200) by a vote of 47 to 11:
“CHI—California Healthcare Institute, whose more than 250 members include our state’s leading research institutes and universities, venture capital firms and biotechnology, medical device and diagnostics companies, applauds the approval of the amendment to the America’s Affordable Health Choices Act of 2009, by Reps. Anna Eshoo (D, CA) creating a pathway for FDA approval of biosimilars, which promotes both price competition and continued biotechnology innovation.
“CHI has supported the development of a science-based biosimilars approval pathway that employs the best science to make sure that products are safe for patients, that encourages price competition among manufacturers, and provides ample incentives to encourage continued private-sector investment in the next generation of breakthroughs.
“CHI supported Congresswoman Eshoo’s earlier legislation (HR 1548, the Pathway for Biosimilars Act) because it appropriately and thoughtfully met these standards. The amendment adopted today, based upon HR 1548 and the biosimilars amendment recently adopted with overwhelming, bipartisan support at the Senate Health, Education, Labor and Pensions (HELP) Committee, incorporates important elements of both and will ensure a pathway benefiting both patients and the innovative life sciences community, which in California employs more than 270,000 people and which has more than 900 products in the pipeline addressing cancer, central nervous system disorders, cardiovascular disease, infectious diseases, immunological and inflammatory disorders and diabetes and other metabolic disorders.
“Specifically, the basis of the HELP proposal, offered by Senators Hagan, Hatch and Enzi and supported by Chairman Kennedy and a dozen other Republican and Democratic members of the committee, provides for 12 years of data exclusivity for innovator biologics. We are pleased the amendment approved today similarly provides for 12 years of data exclusivity as well as the identical FDA regulatory pathway framework from the HELP measure. We are also pleased that the amendment includes important patent dispute resolution provisions from HR 1548 that would establish 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 often licensed to the private sector for commercial development.
“CHI thanks Reps. Eshoo for her tireless efforts, and we look forward to continuing to work with her on this important issue.”
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
.
