BIO Calls For 14 Years of Data Exclusivity in Any Follow-On Biologics Legislation: "WASHINGTON--(BUSINESS WIRE)--Any legislation creating a regulatory pathway for follow-on biologics should provide 14 years of data exclusivity for the pioneering product, the Biotechnology Industry Organization (BIO) said in a paper released today. BIO defines data exclusivity as the time period after approval of the innovator’s product during which the Food and Drug Administration may not approve a follow-on biologic (FOB) product relying to any degree on the safety and effectiveness of the innovator product.
“Biotechnology companies must have some certainty that they can protect their investment in the development of new breakthrough therapies for a sufficient period of time in order to secure the necessary resources from venture capitalists and other funding sources. Such certainty can most predictably be provided through lengthy data exclusivity,” said BIO President and CEO Jim Greenwood. “This is because, due to the very nature of an FOBs regime, the patent system may not provide innovator biologics with effective protection against follow-on manufacturers prematurely entering the market."
