PhRMA Statement on Follow-On Biologics Legislation

Washington, D.C. (June 27, 2008) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today on follow-on biologics:

“Innovative biologic products hold great potential to treat debilitating and life-threatening diseases – including cancer, rheumatoid arthritis and multiple sclerosis.

“PhRMA thinks the cost estimate released by the Congressional Budget Office (CBO) of S. 1695 shows that it is possible to deliver cost savings to patients and the government through introduction of follow-on biologics while maintaining a robust environment that sustains innovation.

“The CBO savings estimate is good news for patients and for public health. It also reinforces the importance of ensuring that science and safety drive the development of an abbreviated pathway for follow-on biologics.

“Development of biologics is scientifically complex, time consuming, and requires significant investment.

“Regrettably, critics use the term ‘evergreening’ to mischaracterize and minimize the important and essential work that innovative pharmaceutical research and biotechnology companies do to continually improve their products and to create better second- and subsequent-generation versions.

“The Food and Drug Administration requires a new application for each biologic, including second- and subsequent-generation biologics; each application includes a full set of clinical trial data demonstrating safety and efficacy. What’s important to note is that as innovator pharmaceutical companies make those tremendous research investments, they do so amid uncertainty that the experimental product will receive regulatory approval.

“Critics would have you believe that the second- and subsequent-generation biologic products that innovator companies introduce have no value. That is simply untrue.

“Second- and subsequent-generation biologics often benefit patients by improving dosing and reducing side effects. These important treatment advances may lead to better patient compliance and improved patient outcomes. What’s more, a broad array of therapeutic alternatives provide treatment options for physicians and for patients whose current therapies have become ineffective or who are unable to tolerate existing therapies.

“Entry of second- and subsequent-generation biologics does not preclude potential competitors from developing or marketing their products.”

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The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $44.5 billion in 2007 in discovering and developing new medicines. Industry-wide research and investment reached a record $58.8 billion in 2007.

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