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Opinion: Biologics lose protection as U.S.-Canada-Mexico trade agreement moves forward

2 monthes ago   |   By STAT

The excision of a key term in the pending United States-Mexico-Canada trade agreement , 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...
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