BIO White Paper Addresses the Challenges of Creating Any Pathway for Follow-On Biologics

WASHINGTON, D.C. (April 30, 2007) -- The Biotechnology Industry Organization (BIO) released today a white paper entitled, “The Difference with Biologics: The Scientific, Legal and Regulatory Challenges of Any Follow-On Biologics Scheme.”

The paper details the legal and regulatory implications of the many important differences between biologics and traditional “small molecule” drugs. Biologics have very different physical structures and characteristics from small molecule drugs as they are generally large complex molecules produced using living organisms in an intricate manufacturing process. Since traditional drugs and their generic counterparts can typically be shown in a lab to have identical chemical structures, the law and regulations provide a straightforward and safe pathway for the approval of generic versions of drugs. In contrast, a follow-on version of a biologic cannot be a physical duplicate of the innovator version—it can only be comparable or similar. Because of the differences in the complexity of the molecules and the importance of the manufacturing processes used to create biologics, the core scientific principles that allow the Hatch-Waxman Act to provide safe and effective generic small molecule drugs do not apply to biologics.

“The scientific, legal and regulatory issues involved in creating any approval pathway for follow-on biologics are complicated,” stated Jim Greenwood, president and CEO of BIO. “We urge Congress to give these issues the thoughtful deliberation they require without unnecessarily rushing the debate and putting patient safety and biomedical innovation at risk.”

The paper discusses how the scientific differences between traditional small molecule drugs and biologics will necessitate differences in the application of the laws and regulations implemented by the Food & Drug Administration and differences in how exclusivity, patent, and trade secret protection issues are interpreted and applied in the context of a follow-on biologics regime.

“In order for the biotechnology industry to continue to produce new life-enhancing and life-saving therapies for patients around the world, there must be the potential for a return on the significant investment required to bring a therapy to market, and a carefully constructed incentive structure must be part of any statutory pathway for follow-on biologics, ” stated Greenwood.

The paper can be accessed at: