Medical DevicesBIO Comments On White House Letter On Biosimilars
Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood issued the following statement regarding the letter sent yesterday from the Obama Administration to House Energy and Commerce Committee Chairman Henry Waxman regarding biosimilars:
"The Biotechnology Industry Organization continues to support strongly the development of a pathway for the review and approval of biosimilars.
"We are extremely concerned that the seven years of data exclusivity called for by the administration in the letter points to a risky short cut to biosimilars. We believe this abbreviated period will undermine the incentives necessary for continued biotech research into breakthrough medicines and cures for diseases such as cancer, multiple sclerosis, Alzheimer"s and HIV/AIDS as well as unmet medical needs.
"As we have consistently said, any pathway to biosimilars should provide a fair period of time for innovators to protect their proprietary data from competitors in order to promote the continued development of breakthrough medicines, therapies and cures. We continue to believe that fourteen years of data exclusivity will strike the appropriate, reasonable and fair balance between our common desire to expand access to breakthrough biotech medicines and the need to preserve the protections necessary to promote further biomedical advances. In addition, it will provide biologics manufacturers with the same effective protections provided to small molecule drug manufacturers.
This is the approach supported by the 110 bipartisan cosponsors of H.R. 1548, the Pathway for Biosimilars Act, along with more than 105 patient advocacy, physician, academic and innovator groups who join us in supporting H.R. 1548.
"We are disappointed the administration chose to base its policy upon the Federal Trade Commission (FTC) report. This report was based upon highly selective assumptions and has been rejected by many members of Congress as fundamentally flawed. Following the recommendations in the report will place at risk the more than 7.5 million high wage, high-quality American jobs supported by the biotech industry and jeopardize our nation"s global competitive advantage in biomedical innovation.
"We look forward to continuing to work with the Obama administration and the Congress to develop a bipartisan pathway to biosimilars that places patient safety at its center, reduces costs, expands access and promotes continued biomedical advances for patients."
BIO