US-Mexico Trade Agreement Elicits Another Battle Over Biologics Data Exclusivity

Agreement in principle between US and Mexico would establish 10 years of data protection for biologic drugs, which AAM opposes.

Flags: United States, Mexico

The US and Mexico reached a preliminary agreement in principle to revise the North America Free Trade Agreement (NAFTA) with a contentious provision for the biosimilars industry: it would establish 10 years of data protection for biologics.

That term is longer than that provided in the US under the Biologics Price Competition and Innovation Act, which gives...

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