Opinion: Biologics lose protection as U.S.-Canada-Mexico trade agreement moves forward
The excision of a key term in the pending United States-Mexico-Canada trade agreement (USMCA), which was approved Thursday by the House of Representatives, that would have assured a minimum of 10-year data exclusivity for newly approved biologic medicines abandons decades of U.S. trade policy that supports expanding intellectual property protection for American biotech and other technology-based businesses.
Data exclusivity precludes a prospective generic competitor who would otherwise launch a biosimilar medicine from referencing the proprietary clinical data developed by the innovator company until after the exclusivity period has expired, thereby increasing the burden on would be competitors and making it more likely that the reference biologic will maintain market exclusivity during the period.
