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AAM highlights barriers to generics, biosimilar access in proposed USMCA

The Association for Accessible Medicines is strongly opposed to the proposed trade agreement USMCA, stating that it fails to achieve one of the principal objectives of the Bipartisan Congressional Trade Priorities and Accountability Act of 2015. AAM said that the proposed provisions will "almost uniformly protect and extend the monopolies of brand-name drug companies," and do not adequately balance innovation with access to medicine.

AAM also said 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 10 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," the organization said.

In a separate, but related development, the Canadian Generic Pharmaceutical Association expressed its opposition to USMCA.

"Canada was not at the table when harmful intellectual property provisions were negotiated between the United States and Mexico," CGPA president Jim Keon said. "The pharmaceutical provisions in USMCA will delay access to competition from biosimilar biologic drugs. Biologic medicines represent the fastest-growing cost segment of healthcare spending, and these delays will be costly to patients, businesses that sponsor employee drug plans, private payers and our industry."

"The United States-Mexico-Canada Agreement is disappointing for the vast majority of Canadians who feel access to more affordable prescription medicines is the most important aspect of the negotiations. A recent poll found that 4-in-5 Canadians feel that it is important that the negotiations should not delay Canadians access to more affordable versions of expensive biologic drugs," CGPA said.
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