Fiocruz to produce API for national manufacture of insulin glargine

On Tuesday (2/25), the Brazilian Ministry of Health announced that Fiocruz and the company Biomm will enter into a production development partnership for the fully national manufacture of insulin glargine. Scheduled for distribution to the Unified Health System (the Brazilian national public system, SUS) in the second half of 2025, the measure is part of the Productive Development Partnerships (PDP) Program. It involves the production of the Active Pharmaceutical Ingredient (API) by the Fiocruz's Immunobiological Technology Institute (Bio-Manguinhos/Fiocruz) at the Strategic Inputs Technology Complex (CTIE), a production plant that will be built in the municipality of Eusébio, in Ceará.

The event held at the Planalto Palace also announced agreements for the production of vaccines and other supplies aimed at strengthening national production for the SUS (photo: Disclosure)

With the drug registered with the Brazilian Health Regulatory Agency (Anvisa), Biomm is currently carrying out the formulation, filling, labeling, and packaging stages of the drug with the API from the Chinese company Gan & Lee. This production arrangement of import and distribution continues until the production of the input at the biofactory in Ceará begins, as the stages of technology transfer advance.

"The API will be produced in our regional office in the municipality of Eusébio, Fiocruz Ceará, which will strengthen the Health Economic-Industrial Complex and foster regional development. We are working on several fronts to strengthen the SUS and for the benefit of the Brazilian population, which will benefit directly from this PDP that will allow for the insulin to be produced 100% nationally," celebrated Fiocruz's president, Mario Moreira.

The pharmaceutical company Gan & Lee has been producing insulin glargine since 2005 and is the owner and responsible for transferring the technology for industrial-scale production of the API and the formulated drug. The documentation, training, and support for the implementation of all processes will be provided by the Chinese entity. The PDP starts with a 5% reduction in the price charged by the Ministry of Health in its last purchase and will be reduced by 1% every year.

The public-private partnership, which could reach 70 million units a year by the end of the project, ensures that this will be the first insulin API production plant in Latin America and will play a strategic role in reducing import dependency.

Implementation therefore assures Brazil a complete production chain for supplying the SUS and greater security in the supply of the product.

Mauricio Zuma, director of Bio-Manguinhos/Fiocruz, explains that Brazil has the fifth largest diabetic population in the world (aged between 20 and 70) and projections indicate that this position will continue for the next 20 years. "The PDP for insulin glargine is an important milestone for Brazilian public health, as Bio-Manguinhos and Biomm will be the only national producers of this drug. The partnership aims to increase access for patients who are not currently treated by the SUS by offering a product that has the advantage of stable and sustained insulin release over a long period, helping to control blood glucose and reducing the frequency of injections compared to short-acting insulins," he said.

"Diabetes is one of the main public health problems when we think of chronic diseases and this announcement is a benefit for the Brazilian population [...] The partnership brings together an innovative and prominent private company with Fiocruz, the Ministry of Health and the Chinese laboratory with this technology, Gan & Lee," commented the ninister of Health, Nísia Trindade Lima, during the ceremony. "The arrangement is very important as it gives us a path to the future: insulin today is a major challenge in the world, with frequent risks of shortages," she added.

The event held at the Planalto Palace also announced agreements for the production of vaccines and other inputs that seek to strengthen national production for the SUS through the Brazilian Health Economic-Industrial Complex. In addition to Moreira, the ceremony was attended by authorities such as President Lula and the CEO of Biomm, Heraldo Carvalho Marchezini.

Strategic Inputs Technology Complex A partnership between Fiocruz and the state of Ceará, the Strategic Inputs Technology Complex is part of the Ministry of Health's strategy to strengthen the Health Economic-Industrial Complex and will receive around R$ 1 billion in investment from the Federal Government's New Growth Acceleration Program (PAC). The biofactory will be involved in the production of active pharmaceutical ingredients (APIs) for various biopharmaceuticals, including drugs to treat some types of cancer, chronic diseases, inflammatory diseases (such as rheumatoid arthritis and Crohn's disease), and growth hormones.

Insulin glargine

Achieving and maintaining optimal glycemic control is crucial in managing diabetes to prevent complications. With the growing global prevalence of the disease, the use of insulin glargine is a major factor and ongoing advances in treatment contribute to the popularity and ease of insulin administration.

Currently, SUS has established and incorporated the Clinical Protocol and Therapeutic Guidelines (PCDT) for Type 1 and Type 2 Diabetes Mellitus, which contains recommendations for the use of long-acting insulin analogues. Insulin glargine, like basal insulin, plays a key role in controlling fasting blood glucose levels, contributing to overall glycemic control. It has the advantage of providing a stable and sustained release of insulin over a prolonged period. This helps to control blood glucose and reduce the frequency of injections compared to short-acting insulins.