Thera Health Policy & Access Managing Director Discusses Biosimilars and USMCA Review with El Economista
July 2026
Thera Health Policy & Access is pleased to share that its Founder and Managing Director, José Luis Cárdenas Tomažič, was interviewed on June 25, 2026, by renowned Mexican healthcare journalist Maribel Ramírez Coronel of El Economista, one of Mexico’s leading business and policy newspapers.
The interview explored the implications of the upcoming review of the United States-Mexico-Canada Agreement (USMCA/T-MEC) for the Mexican pharmaceutical sector, with a particular focus on biosimilars, intellectual property, regulatory policy, trade rules, and patient access to innovative medicines.
Drawing on more than three decades of experience in health policy, market access, regulation, and pharmaceutical strategy across Latin America, José Luis Cárdenas highlighted both the risks and opportunities that the USMCA review presents for Mexico. He emphasized the importance of achieving a balanced framework that protects innovation while fostering competition and improving patient access to life-saving biological therapies.
The discussion also addressed regulatory and trade barriers affecting biosimilars, the potential impact of pharmaceutical intellectual property provisions, and opportunities to strengthen the competitiveness of Mexico’s biotechnology and biosimilar manufacturing sectors within North America.
The original interview was published in Spanish by El Economista (see here https://www.eleconomista.com.mx/empresas/biosimilares-mexico-revision-t-mec-riesgo-mayor-rezago-u-oportunidad-expansion-20260625-820203.html). An English translation is provided below for the benefit of our international audience.
Biosimilars in Mexico Ahead of the USMCA Review: Greater Risk of Delay or Opportunity for Expansion?
Mexico continues to lag behind its USMCA partners in the availability of biosimilars—the highly similar versions of advanced biologic medicines that offer significant benefits for the treatment of complex diseases.
With only days remaining before the joint review of the United States-Mexico-Canada Agreement (USMCA), scheduled to begin on July 1, access to biosimilar medicines in Mexico stands at a crucial crossroads. What is at stake is not only an industrial and commercial issue, but also whether thousands of patients will continue waiting years for access to more affordable treatments that are already available in the United States and Canada.
Mexico remains behind its North American partners in the availability of biosimilars. While the United States and Canada already have well-established and growing markets for more affordable versions of biological therapies in areas such as oncology, rheumatology, and endocrinology, many of these products take several additional years to reach the Mexican market. This gap limits therapeutic options for patients and continues to place significant financial pressure on the healthcare system.
In an interview with José Luis Cárdenas Tomažič, Founder and Managing Director of Thera Health Policy & Access, a Think & Do Tank focused on health policy and market access with a particular emphasis on Latin America, he explained that the current environment presents both risks and opportunities for Mexico.
According to Cárdenas, the principal risk is the potential strengthening of pharmaceutical intellectual property standards. Among the issues that have been discussed are regulatory data protection for biologic products as well as possible changes to the patent linkage system between the Mexican Institute of Industrial Property (IMPI) and the national health regulator, COFEPRIS.
Should the negotiation process lead to more stringent intellectual property standards, there is a concrete risk that the current access gap could widen further. A more restrictive regulatory framework could delay biosimilar competition, reinforcing Mexico’s position as a secondary market where these medicines arrive significantly later than in the United States and Canada.
In this regard, Cárdenas noted that Mexico’s opportunity concerning patent linkage lies in achieving a more balanced system by incorporating some of the safeguards present in the United States’ Hatch-Waxman framework, which facilitates the timely entry of competition while preserving incentives for innovation.
The Opportunity: Better Conditions for Exporting Mexican Biosimilars
At the same time, the USMCA review opens a potential window of opportunity for Mexican companies manufacturing or developing biotechnology products and biosimilars.
Currently, there is tension between the agreement’s rules of origin and the criteria applied by U.S. Customs authorities. While the treaty recognizes a medicine as originating in the country where substantial transformation occurs—that is, where the finished pharmaceutical product is manufactured—the United States often applies a standard based on the origin of the active ingredient.
This inconsistency creates uncertainty and potential barriers for Mexican exports. If the review process succeeds in providing greater clarity and harmonization regarding rules of origin, Mexican biosimilar manufacturers could gain more favorable access to the U.S. market without facing additional tariff-related obstacles.
As a result, the same negotiation process that could make it more difficult for biosimilars to enter Mexico could also facilitate the export of biosimilars manufactured in Mexico to some of the largest and most competitive healthcare markets in the region.
Toward a Patient-Centered Balance
According to Cárdenas, the fundamental challenge for Mexico during the USMCA review is to achieve a balanced outcome that combines the protection of innovation with the promotion of competition.
A successful agreement should avoid further widening the current biosimilars gap while creating favorable conditions for the Mexican biotechnology industry to export and compete on equal footing within North America.
The USMCA review is not merely a trade exercise. It represents one of the most significant opportunities in the coming years to define the type of biologics ecosystem Mexico intends to build: one that continues to rely on delayed and costly imports, or one that leverages domestic manufacturing capabilities to generate greater competition, lower prices, and more therapeutic options for patients.
The decisions made during the coming weeks will have a direct and lasting impact on access to high-cost treatments throughout the country.
Ultimately, taking advantage of this opportunity will depend on Mexico’s ability to defend, at the negotiating table, both timely access to biosimilars and the development of its own biotechnology manufacturing capabilities.
About Thera Health Policy & Access
Thera Health Policy & Access is a boutique Think & Do Tank specializing in health policy, market access, public affairs, regulation, trade policy, and healthcare innovation across Latin America and beyond. Through evidence-based analysis and strategic advisory services, Thera supports governments, healthcare stakeholders, industry leaders, and patient organizations in advancing sustainable access to healthcare solutions.
