BIO Provides Key Principles on Follow-On Biologics to Legislators

Any Statutory Pathway for the Approval of Follow-On Biologics Must Protect Patient Safety and Preserve Incentives to Innovate

WASHINGTON, D.C. (March 29, 2007) – Today, the Biotechnology Industry Organization (BIO) released letters which the organization sent to Senators Ted Kennedy (D-MA) and Mike Enzi (R-WY) and to Representatives John Dingell (D-MI) and Joe Barton (R-TX) to lay out a detailed set of key principles which should guide the creation of any statutory pathway for the approval of follow-on biologics.

“In order to ensure that new pioneer biotechnology products continue to reach patients and physicians, any statutory pathway for the approval of follow-on biologics must protect patient safety and preserve incentives to innovate,” stated BIO President and CEO Jim Greenwood. “If Members of Congress agree with these fundamental values, we strongly urge them to adopt these principles when drafting legislation that aims to create a pathway for follow-ons.”

These key principles include:


· Ensure Patient Safety. Patients should not have to accept greater risks or uncertainties in using a follow-on product than an innovator's product. Congress should ensure that approval of follow-on biologics is based on the same rigorous standards of safety, purity, and potency applied by the Food and Drug Administration (FDA) for the approval of pioneer biotechnology products.


· Recognize Scientific Differences Between Drugs and Biologics. Biologics are much more complex than small molecule chemical drugs. Thus, Congress should recognize that the methods used to show that one chemical drug is the same as another are different from and insufficient for biologics and that small product or manufacturing differences in biologics can result in significant safety and/or effectiveness differences.


· Maintain the Physician-Patient Relationship. The current state of science is not sufficient to establish interchangeability for complex follow-on biologics. Indeed, the FDA recently stated that it “has not determined how interchangeability can be established for complex proteins.” Accordingly, Congress should ensure that patients are not given follow-on biologics unless expressly prescribed by a physician.


· Preserve Incentives for Innovation. In order to preserve incentives to research, develop and manufacture new innovative therapies and cures, as well as new indications for such products, any statutory pathway for follow-on biologics must include substantial non-patent data exclusivity; respect intellectual property and other legal rights; and provide adequate notice and process rights.


· Ensure Transparent Statutory and Regulatory Processes. Manufacturers of innovator products should be provided full and fair opportunities to engage Congress and other stakeholders in a meaningful public process. Further, any such pathway must require that FDA follow a transparent and public process in determining data requirements for the approval of specific follow-on biologics.


· Continue to Prioritize FDA Review and Approval of New Therapies and Cures. In order to avoid slowing down FDA’s review and approval of new therapies and cures, many for currently untreatable and serious diseases, Congress must ensure that workload associated with these new applications does not harm FDA’s ability to efficiently review new drugs and biologics and that new treatments continue to have the highest review priority.


Greenwood also reiterated the need for Congress to consider a pathway for approving follow-on biologics independent of the legislation reauthorizing the Prescription Drug User Fee Act (PDUFA).

“Before a framework for follow-on biologics can be established, Congress must carefully consider and resolve complex scientific, legal, and economic issues,” Greenwood noted. “Meanwhile, it is important that Congress complete the PDUFA reauthorization in a timely manner. We believe that attaching follow-on biologics legislation to PDUFA would jeopardize reauthorization of the user fee program to the detriment of patients waiting for new therapies, FDA’s internal scientific capabilities, and biomedical innovation.”

The principles are available at .