AAM Opposes Barriers to Generic Drug and Biosimilar Access in Proposed US-Mexico-Canada Agreement (USMCA)

WASHINGTON DC (October 1, 2018) – AAM is extremely concerned that the proposed US-Mexico-Canada trade agreement will provide a windfall for brand-name drug manufacturers and raise prescription drug prices for patients in the United States.

The proposed trade agreement USMCA fails to achieve one of the principle objectives of the Bipartisan Congressional Trade Priorities and Accountability Act of 2015 (TPA), because the proposed provisions – which will almost uniformly protect and extend the monopolies of brand-name drug companies – do not adequately balance innovation with access to medicine as Congress has required.

The approach extends monopoly protections for manufacturers of brand-name drugs and biologics that will stifle biosimilar competition, hurt American exporters, and decrease patient access to medicines.

Generic drug and biosimilar manufacturers strongly support the Administration’s efforts, as stated in President Trump’s drug pricing blueprint to enhance the “availability, competitiveness, and adoption of biosimilars as affordable alternatives to branded biologics.” Yet we are deeply concerned that increasing branded biologic exclusivity to ten years in a revised trade agreement, as well as adding other patent barriers to generic and biosimilar access, will have the exact opposite effect, slowing the development of biosimilars that we need in the U.S. and decreasing prescription drug competition.

AAM looks forward to working with the Administration, Congress and other stakeholders to remove barriers to patient access to generic and biosimilar medicines and include provisions consistent with U.S. law to encourage access to safe, effective and affordable generic and biosimilar medicines.

Rachel Schwartz 
202.249.7147 (o)
202.251.8881 (c)


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. 

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 at www.biosimilarscouncil.org.


Association for Accessible Medicines


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