New Bipartisan, Consensus Bill Points to Right Path to Biosimilars

WASHINGTON, DC – (March 17, 2009) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement regarding H.R. 1548, the Pathway to Biosimilars Act, introduced today by Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA) and Joe Barton (R-TX) that would develop a regulatory pathway for approving biosimilars, medicines which are similar to pioneering biomedical therapies and treatments:

“The legislation introduced today by Representatives Eshoo, Inslee and Barton bill lays out an effective, reasonable and safe pathway to biosimilars.  It is the right medicine for lowering costs, ensuring patient safety and providing fair, responsible incentives for continued biotech research into cures for diseases such as cancer, multiple sclerosis, Alzheimer’s and HIV/AIDS.  In short, the bill provides patients with the right balance between innovation and competition. 

“This bill will lead to real solutions for our nation’s health care challenges and provide real hope for patients.  It will help reduce costs by enabling additional competition among biologics but at the same time help safeguard patient safety by requiring demonstration of the purity, safety and effectiveness of biosimilars.  More, the bill includes the incentives necessary for biotechnology researchers to develop new breakthrough therapies and potential cures.

“The Eshoo-Inslee-Barton bill establishes parity with the outcomes of the Hatch-Waxman regime developed for traditional pharmaceuticals, balancing the need to increase access, lower costs, ensure drug safety and promote continued biomedical breakthroughs.  At the same time, the bill recognizes the fundamental differences between biologics and traditional pharmaceuticals.  Traditional pharmaceuticals are produced by machines and are relatively simple for generics makers to copy.  Innovative biologics, on the other hand, are grown from living cells and are so molecularly complex that current science does not allow for an exact copy to be made, as the Food and Drug Administration (FDA) has recognized.  The fact that the medications are different calls for a slightly different set of rules around safety and competition incentives to achieve the same goals.

“BIO commends Reps. Eshoo, Inslee and Barton for their continued efforts to establish a pathway for the development and approval of biosimilars.  We are pleased to join them, their 35 additional Congressional co-sponsors, and a diverse array of patient, physician and other organizations in announcing our support for this legislation.  We look forward to working with the Congress as they consider this balanced, landmark bill.”

Upcoming BIO Events

BIO IP Counsels' Committee Conference
March 25–27, 2009
Phoenix, AZ

BIO National Venture Conference
March 31–April 1,2009
Boston, MA

BIO Windhover 2009
April 13-15, 2009
New York, NY

BIO-LES Business Development Basics Course
May 15–17, 2009
Atlanta, GA  

BIO-LES Advanced Business Development Course
May 15–17, 2009
Atlanta, GA 

BIO Executive Presentation Workshop
May 17, 2009
Atlanta, GA

BIO Human Resources Conference
May 17-19, 2009
Atlanta, GA

2009 BIO International Convention
May 18-21, 2009
Atlanta, GA

BioEquity Europe
June 9-10, 2009
Munich, Germany

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