New Proposed Biosimilars Pathway Filled With Potholes

Proposal Jeopardizes Future Medical Breakthroughs

WASHINGTON, DC (March 11, 2009) – The following statement was issued by Biotechnology Industry Organization President and CEO Jim Greenwood regarding legislation introduced today by Reps. Henry Waxman (D-CA), Frank Pallone (D-NJ), and Nathan Deal (R-GA) to establish a pathway for the approval of biosimilars:

“The Biotechnology Industry Organization (BIO) continues to support strongly the development of a pathway for the review and approval of biosimilars.  Unfortunately, the legislation introduced today would take patients and our industry down the wrong path – a path that jeopardizes the continued development of new breakthrough therapies and potential cures for debilitating diseases such as multiple sclerosis, HIV/AIDS and Alzheimer’s.   This legislation sets a path that jeopardizes our ability to help meet President Obama’s call for a cure to cancer ‘within our time’ and help realize the promise of stem cell research. 

“This bill seeks to cut prices but instead cuts corners.  This proposal leads us off the map as we seek an effective, fair and safe pathway to a biosimilars market.  

“The legislation introduced today does not strike the necessary balance for patients or the economy.   Any biosimilars legislation must ensure safe and effective biosimilars, promote the continued development of new therapies and cures, and ensure the benefits of additional competition among biologics through the entry of biosimilars.  

“Parity between the generic drug regime for small molecules and a pathway for approval of biosimilar drugs is desirable and can be achieved.  However, parity must focus on the outcome of the respective pathways and not be distracted by superficial similarities.  A pathway must recognize that biologics are much more complex than traditional pharmaceuticals and that the regulatory standard for approval of biosimilars will be based on similarity rather than sameness as is the case with traditional generic drugs.  As the U.S. Food and Drug Administration (FDA) has noted, biotech drugs are so molecularly complex that they are almost impossible to map accurately with existing science.  Even minor differences in the purity of a biotech drug can change its efficacy and safety.  We can take no short cuts to safety when it comes to biosimilars.

“Biotechnology represents the cutting edge of medical research. The wrong path to biosimilars jeopardizes our ability to develop medical advancements and the next generation of breakthrough therapies.  More, the wrong path to biosimilars jeopardizes our ability to maintain our nation’s competitive advantage in biomedical innovation and help drive our nation’s innovation economy:  Our industry supports more than 7.5 million jobs nationwide  These jobs are generally high-wage, high-value, and often ‘green.’ 

“We urge Congress to ensure that any pathway for approving biosimilars is grounded in sound science, safeguards patient safety, and preserves incentives to develop future breakthrough therapies and cures.”