Biosimilar stakeholders praise removal of biologic exclusivity provisions from USMCA

Center for Biosimilars

11 December 2019 - An agreement on the United States–Mexico–Canada Agreement, a trade deal that updates the North American Free Trade Agreement, has been reached, and proponents of biosimilars and generics have cause to celebrate after the removal of provisions that some said would hinder competition.

The full text of the newly agreed version of the deal is yet to be publicly released. 

However, the chairman of the House Committee on Ways and Means, Richard Neal, D-Massachusetts, said in a statement outlining features of the final agreement that House Democrats were successful in their attempts to remove provisions of the deal that would have required all parties to provide at least 10 years of exclusivity for biologic drugs, to remove provisions that would have allowed patent ever-greening on drugs, and to cut provisions that would allow 3 extra years of exclusivity for clinical information submitted in connection with new uses of existing products.

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Michael Wonder

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Michael Wonder