PhRMA Statement on Rep. Eshoo’s Follow-on Biologics Bill

PhRMA Statement on Rep. Eshoo’s Follow-on Biologics Bill

Washington, D.C. (March 17, 2009) – Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today on follow-on biologics:

“The legislation offered today by Reps. Anna Eshoo, Joe Barton, Jay Inslee and 34 other bipartisan cosponsors represents a positive step forward. We appreciate the seriousness with which the bill sponsors have examined the challenge of how to responsibly create a regulatory approval pathway for follow-on biologics.

“PhRMA continues to support an abbreviated approval pathway that protects patient safety, is based on sound science, and recognizes the unique role of the biotechnology sector in providing hope to patients and as a valuable contributor to the U.S. economy.

“It is crucial to strike an appropriate balance between making room for additional competition and maintaining strong incentives for the investment needed to seize the extraordinary opportunities for medical advances and economic growth offered by the biotechnology sector.

“Due to the research-intensive nature of the biotechnology sector, appropriate incentives for continued investment in innovation include both robust patent protections and a base period of data exclusivity of at least 14 years.

“Today, more than 600 biotechnology medicines are in development, including 250 to treat cancer. Each of the therapies in development has the promise of saving, extending and improving lives across the U.S. America’s pharmaceutical research and biotechnology companies lead the world in developing innovative medicines and, last year alone, invested $65.2 billion in research and development.

“At a time when President Obama has called for a cure for cancer in our lifetime, PhRMA remains hopeful that legislation enacted by this Congress supports medical advances that will help achieve the President’s admirable goal.

“In the interest of patient safety, federal regulators must make approval decisions in a manner that is science-based, transparent and puts safety first. That’s because manufacturing, testing and proving the safety and efficacy of biologics, therapies based on living organisms, is complex.

“Unlike small molecule generics – which earn regulatory approval by demonstrating their active ingredient is the same as the innovator medicine – follow-on biologics are not the same as their reference product. Slight differences between biologic medicines produced by different manufacturers can dramatically impact how the biologic works.

“Current testing methods cannot detect all of the differences between follow-on biologics and the reference biologic that may adversely impact patient health. For that reason, Congress must require clinical trials in patients to confirm that follow-on biologics are as reliably safe and effective as the reference biologic.”


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 $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in 2008.

PhRMA Internet Address: www.phrma.org

For information on how innovative medicines save lives, visit: www.innovation.org

For information on the Partnership for Prescription Assistance, visit: www.pparx.org

For information on the danger of imported drugs, visit: www.buysafedrugs.info

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 $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in 2008.

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