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US-Mexico-Canada Trade Agreement Sets 10-Year Floor For Biologics Market Exclusivity

 
• By Brenda Sandburg

USA's 12-year-plus scheme won't change, but Canada and Mexico must offer sponsors more than previously; biosimilar industry bemoans lack of incentives for competition. Trade pact also specifies damages award options and links regulatory review to patent disputes.

Separated jigsaw puzzle pieces with U.S., Canada and Mexico flags. NAFTA trade agreement members concept. 3D Illustration.

The new US-Mexico-Canada trade agreement will not change a key element of US law as biologics will be able to retain 12 years of market exclusivity. The proposed treaty specifies that a biologic is to receive market protection "for a period of at least 10 years from the date of the first marketing approval" of the product.

The US Biologics Price Competition and Innovation Act specifies that a biosimilar application cannot be approved until 12 years after the date on which the reference product was first licensed. The deal will not change that floor, but would curtail efforts to make the period less than 10 years

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