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.
