Biologics access threatened by US-Mexico-Canada agreement, says biosimilar industry

By Flora Southey

- Last updated on GMT

(Image: Getty/Padrinan)
(Image: Getty/Padrinan)

Related tags Biosimilars Biologics Mexico Canada

The US, Mexico and Canada have agreed a trade deal that includes 10 years of data protection for biologics.

According to the White House, the proposed agreement includes a “modernised, high-standard chapter that provides strong protection and enforcement of intellectual property rights.

“This includes 10 years of data protection for biologic drugs and a large scope of products eligible for protection.”

US President Trump voiced his support​ of the proposal earlier this week, describing the agreement as a “great deal” ​that “opens markets to our…manufacturers, reduces trade barriers to the US and will bring all three great nations together in competition with the rest of the world”.

However, generic drug and biosimilar associations in the US and Canada do not agree, raising concerns the proposal will decrease drug competition.

According to the US Association for Accessible Medicines, the association is “extremely concerned” ​the agreement will provide a ‘windfall’ for brand-name drug manufacturers.

“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,” ​said the association in a statement​, adding that such patent barriers will slow the development of biosimilars and decrease drug competition.

In Canada, the Canadian Generic Pharmaceutical Association (CGPA) also raised concerns that extending the period of market exclusivity for biosimilars from eight to 10 years would hinder competition.

“Canada was not at the table when harmful intellectual property provisions were negotiated between the United States and Mexico,”​ said CGPA president Jim Keon in a statement​.

“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,”​ he added.

Related topics Markets & Regulations Biosimilars

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