Biosimilars Council Joins Other North American Generic Drugmakers in Rejection of New Exclusivity Period for Biologics

Friday August 31, 2018

This week, the United States announced that it has reached a preliminary agreement with our North American counterparts, Canada and Mexico, on certain provisions of the North American Free Trade Agreement (NAFTA). One of these provisions focuses on biologic drugs – specifically, the length of time a brand has data exclusivity (i.e. a monopoly).

The preliminary agreement imposes longer drug exclusivity periods, increasing the length of time that brand-name companies have a monopoly over the market. This effectively halts competition, discouraging innovation, decreasing access for patients to needed treatments, and increasing costs.

North America’s generic associations, including the Association for Accessible Medicines (AAM) and it’s Biosimilars Council, the Canadian Generic Pharmaceutical Association, and the Mexican Association of Generic Medicines have rejected this preliminary agreement, stating the “trade understanding between the U.S. and Mexico to extend brand name biologic data protection to ten years will harm patients in our three countries who seek more affordable medicines.”

It’s important to understand that this is just a preliminary agreement – Congress must vote prior to final passage, meaning there is still time to act, preserving patient access to important generics and biosimilars. Encourage Congress to act now to oppose the inclusion of monopoly protections for brand-name drugs:

Read the statement here:

About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.

About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 23 percent of total drug spending. Additional information is available at

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