Latin America Roundup: Brazil and Colombia advance public drug-making initiatives

Latin American countries have experienced a recent clamor for initiatives to increase access, reduce costs, and avert shortages of generic drugs. Still, only Brazil has made government production of generic drugs a cornerstone of its national public health strategy.

On 5 March, Brazil’s Fundação Oswaldo Cruz (Fiocruz) – a national public health foundation – announced an agreement with Boehringer Ingelheim that would allow Fiocruz to manufacture generic empagliflozin, a diabetes drug, for use in Brazil’s public health system.

The effort follows a successful project by Fiocruz to facilitate local generic production of pramipexole, a Boehringer Ingelheim Parkinson’s disease drug. That deal was reached after the company said it was withdrawing it from the Brazilian market.

Fiocruz’s drug-making lab, Farmanguinhos, began manufacturing pramipexole in 2018. In December 2023, Fiocruz and ANVISA, Brazil’s medicines agency, announced that other Brazilian laboratories could begin producing pramipexole using the publicly made products as references. Empagliflozin will likely follow a similar pathway.

Recently, other Latin American nations have been exploring producing generic medications. On 16 March, Colombia’s National Food and Drug Surveillance Institute (INVIMA) announced an alliance with the University of Antioquia in Medellín to begin laying the groundwork for the public manufacture of medicines in Colombia.

While no specific molecules or medicine classes were mentioned, the initiative seeks to bring together professionals from both institutions to discuss “the standardization, validation, verification and implementation of test methods” needed to create Colombia’s first public production plant for medicines, according to INVIMA.

Fiocruz Statement, INVIMA Statement (Spanish)

Mexico’s COFEPRIS aims to ease clinical research in generics

Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS) had taken measures to “strengthen the ecosystem” of generics clinical trials by “[optimizing] the evaluation of interchangeability protocols and bioequivalence studies,” according to an 8 March statement.

The effort is designed to promote clinical research in Mexico and to help guarantee population access to generic and biosimilar medicines, according to the statement. However, the measures would also likely increase possibilities for the export of pharmaceutical products, especially generics, to the US, a goal that aligns with Mexican industry priorities. Earlier the same week, US Pharmacopeia announced it had hosted a meeting and signed a new memorandum of understanding with Amelaf, a group representing Mexican manufacturers.

COFEPRIS has included industry in its recent discussions on regulatory changes that would help generics and biosimilars manufacturers. Industry representatives took part in talks on how to align interchangeability criteria for trials, COFEPRIS said in its statement and offered feedback on the most frequent problems encountered. COFEPRIS said the discussions would lead to changes to its Digipris clinical trials platform.

In a separate statement issued days later, COFEPRIS said it authorized 12 new clinical trials in recent weeks, including a Phase 1 study of a pediatric pneumonia treatment.

COFEPRIS Statement (Spanish)

Salvadoran health officials accused of ignoring pharmacovigilance warnings

El Salvador’s health ministry ignored repeated warnings by government pharmacovigilance experts and continued to distribute products flagged for withdrawal, according to an investigation by the newspaper La Prensa Gráfica published on 17 March.

Some two dozen internal communications obtained by La Prensa Gráfica show that between 2021 and 2023, the quality control lab of the country’s Direccion Nacional de Medicamentos (DNM) had deemed five lots of medicinal products unfit for consumption and recommended they be withdrawn by the Health Ministry.

The ministry did not act on the warnings, as the products – four antibiotics and a contraceptive injection – continued to be distributed through its clinics for up to two years afterward. Indeed, the ministry-initiated purchases of some medicines after the DNM experts had expressed concerns.

The flagged products were of Chinese, Guatemalan and Indian manufacture, and the reasons for the warnings included faulty packaging and inadequate levels of active ingredients. In the case of the injectable contraceptive, the product was deemed to contain suspicious sediments, and tests also revealed inadequate levels of medroxyprogesterone. The situation evoked a 2021 scandal in Chile in which substandard contraceptives were distributed in government clinics, resulting in hundreds of unwanted pregnancies.

La Prensa Gráfica Article (Spanish)

Brazil approves gene therapy to treat hemophilia

ANVISA has given the green light to a gene therapy to treat hemophilia A in adults, the agency said in a news release on 7 March. The product, marketed as Roctavian by the Brazilian subsidiary of the U.S.-based company BioMarin Pharmaceutical, was approved by the US Food and Drug Administration in June 2023.

The product had been tested in Brazil, beginning in 2018, in a phase 3 study. Brazil contributed the largest number of patients to that study, ANVISA noted.

Since 2020, when it approved its first two gene therapy products, Brazil has led Latin America in approvals of gene therapies. However, the high costs of these agents to Brazil’s public health system have generated controversy. Roctavian, a one-time treatment, is listed at nearly $3 million per patient in the United States, though its cost in Brazil could be substantially less. Brazil is home to a large population with hemophilia, ranking 4^th after India, China, and the US, and the Brazilian government funds the lion’s share of hemophilia treatments.

ANVISA Statement

Latin America Roundup: Brazil and Colombia advance public drug-making initiatives

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