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The new version of the North American Free Trade Agreement between the U.S., Canada, and Mexico is prompting concerns among generic drug makers and consumer advocates who argue language that is designed to bolster intellectual property rights for medicines will hurt taxpayers and patients.

At issue is a provision that would grant 10 years of marketing exclusivity for biologics, which are pricey medicines used to combat a wide variety of diseases, including many cancers. The language means that a company that wants to sell a lower-cost version of a brand-name biologic, which is known as a biosimilar, would be prevented from doing so for a decade.


By including this mandate, advocacy groups and generic companies say the new trade agreement would maintain higher prices for governments and consumers by forestalling availability of biosimilars, which are nearly identical variants of biologics that are expected to provide the same result in patients.

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