Dear Chairman Pallone and Ranking Member Deal:
On behalf of the Biotechnology Industry Organization (BIO), I am writing to thank you for your questions regarding the important issue of follow-on biologics. The questions, along with responses thereto, are attached.
BIO strongly supports the creation of a follow-on biologics pathway and believes that Congress should pass the right bill as soon as possible this year. This legislation should recognize that biological products are fundamentally different from traditional drugs in their complexity, development and production processes, and that follow-on biologics are not generic drugs. BIO believes that such a pathway must fully address both how to ensure patient safety and how to maintain incentives that spur continued investment and innovation, including strong protections for intellectual property rights. BIO strongly believes that it is time for all parties to work together to place patient needs first by passing a pro-patient, pro-innovation, pro-science follow-on biologics bill, and we hope the answers which are provided herein will spur consideration by the Committee of such legislation.
The Honorable Jim Greenwood
President and CEO
Biotechnology Industry Organization