Latin America Roundup: Mexico unveils ambitious biosimilar strategy

Regulators with Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS) announced on 9 February a detailed plan that describes working closely with industry to assure regulatory certainty for biosimilar medications and jump-start their mass production in Mexico.

The announcement comes at a time when many biological products are losing patent protection, and manufacturers worldwide are seeking to produce cheaper biosimilars for local markets. Mexico’s push to a seamless new regulatory path is meant to both assure that more Mexicans have access to these products and to establish the country as a regional producer of biosimilars.

The COFEPRIS plan seeks to “promote the development of biocomparable biotechnological medicines,” “establish a robust institutional and regulatory framework, aligned with international standards, that provides regulatory certainty to manufacturers established in Mexico,” and “promote the capacity of the industry, through specific regulatory support strategies in all phases of research and production,” the agency said in a news release.

COFEPRIS, in the same announcement, described two new expert teams that will work on biosimilars: a Specialized Unit in Biosimilar Biotechnological Medicines, which will streamline regulatory processes for biosimilars, and a Pharmaceutical Development Committee for Biosimilar Biotechnological Medicines, which will work with local manufacturers to support “an ecosystem conducive” to the development of these products.

In an editorial in El Economista, Mexico’s business newspaper of record, health analyst Maribel Ramírez Coronel praised the COFEPRIS initiative as unique in the region for integrating the input of industry to the degree that it has. If it is successful, the initiative could “generate enormous benefits” for Mexico’s public health and economy, she wrote.

The initiative was announced with only months to go before the end of the current presidential term in Mexico. Only once in Mexico’s history has a COFEPRIS head been retained after a transfer of power. A desire to keep the biosimilars plan on track, Ramírez Coronel wrote, could incline an incoming government to retain COFEPRIS head Alejandro Svarch in his position. Otherwise, she wrote, pressure from Mexican industry will be key to keeping the initiative moving into the next administration.

COFEPRIS (Spanish)

Report details long wait times for new oncology, orphan drugs in Latin America

A new report by the Federación Latinoamericana de la Industria Farmacéutica (FIFARMA) and the pharmaceutical consulting firm IQVIA has found that time to any reimbursement, public or private, of novel oncology and orphan medications varied widely across Latin American countries between 2014 and 2021.

Countries’ average wait times ranged from three years following approval by the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) to nearly 6 years.

The report, published 15 February, traced 228 oncology and orphan disease drugs, all of them approved between by FDA or EMA, in eight countries: Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico and Peru. The investigators measured the time from FDA or EMA approval to local approval and then from local approval to private and/or public reimbursement for the same drugs.

The researchers found that 57% of the drugs had been approved in at least one of the eight countries; 38% were reimbursed through public health systems in at least one country, and time between FDA or EMA approval and any reimbursement averaged 1,641 days, or 4.5 years, across countries, with Argentina having the shortest total time at 966 days and Mexico the longest, at 2,703. The study’s results were likely affected by the COVID-19 pandemic, its authors acknowledged, during which regulators and health systems were overwhelmed and fewer molecules were moved forward.

Time from FDA or EMA approval to marketing approval by national regulatory bodies also varied widely in the study, from 517 days in Brazil to 980 days in Colombia. And while Chile and Mexico had times to local marketing approval that were on the faster end, both had exceptionally long times – 1,184 and 1,215 days, respectively – between approval and reimbursement.

Colombia, despite having the longest wait times to local marketing approval of any of the countries, saw a rate of public reimbursement of approved molecules higher than the rest, at 35%. Mexico saw the second-highest rate of public reimbursement, at 24%.

In Argentina, where time between local approval and availability was only 156 days, the fastest in the study, only 1% of the new molecules were reimbursed through public health channels. More than a third were not reimbursable through any insurance, and could only be purchased privately.

Report

Rossi to return to Colombia’s INVIMA

Nearly a year after having stepped down from a six-month term as acting director of Colombia’s National Food and Drug Surveillance Institute (INVIMA), epidemiologist Francisco Rossi Buenaventura is again poised to take the agency’s helm – this time as its confirmed director. While the Colombian government did not make a formal announcement, Dr. Rossi’s resume was published on the agency’s website as an applicant for the top post on 7 February, suggesting his appointment was imminent.

As INVIMA acting director from September 2022 to March 2023, Rossi had championed the creation of a multi-country Latin American medicines agency, which would encourage mutual regulatory reliance among regional agencies in lieu of reliance on decisions by European and North American agencies. The effort, led by Colombia and Mexico, had stalled, but could see renewed interest with Rossi’s return.

Rossi is a frequent critic of the international pharmaceutical industry and, especially since the COVID-19 pandemic, a champion of health sovereignty in Colombia, of low-cost generic products, and of streamlining the number and variety of medicines in the country. In his previous term he had generated controversy with comments praising the country’s then health minister for rejecting importations of medicines meant to alleviate ongoing shortages, saying that allowing them would discourage domestic production.

In an interview last March after his departure from INVIMA, Rossi identified a tangled bureaucracy and elaborate fee system as among INVIMA’s most pressing problems. However, on the topic of INVIMA’s notoriously long backlog for new product approvals, Rossi was defensive. “Multinational industry lives on new products,” he claimed. “This focus on new products has even permeated regulatory agencies so that approvals are made very quickly, so that they are done expeditiously. And we have had bad experiences.”

Upon the news that Rossi would be back at INVIMA, representatives of the Colombian industry umbrella group AFIDRO began publicly urging him to tackle the problems of slow processes and long backlogs.

The INVIMA workers’ unions, which have decried the lack of a confirmed director for months, responded negatively to the choice of Rossi, saying that they did not support his confirmation. Several union groups argued in a joint letter to Colombia’s president, reproduced in part by the newspaper El Tiempo, that Rossi, when he was acting director, had presented a restructuring plan for the agency that marked “a clear path towards regression in terms of regulation … yet is not clear in the methodology to be followed or the resolution of current problems.”

INVIMA (Spanish)

Latin America Roundup: Mexico unveils ambitious biosimilar strategy

Related topics

Recommended content

Welcome to the new RAPS Digital Experience