Fiocruz and Pfizer sign agreement making it more affordable to treat rheumatoid arthritis

The Institute of Drug Technology (Farmanguinhos/Fiocruz) has signed a technology transfer agreement for the production of the medicine tofacitinib citrate, a generic clone of Xeljanz®. The partnership was signed with Pfizer Brazil on Wednesday (12/20), in Rio de Janeiro. The aim is to strengthen national production and increase public access to the treatment of immune-mediated inflammatory diseases, i.e. those triggered by imbalances in the immune system, such as rheumatoid arthritis.

Directors of Fiocruz and Pfizer signed the agreement at the Moorish Castle (photo: Lean Morgado)

"We are delighted to announce this important partnership. The agreement is part of a structuring strategy by Fiocruz to continuously expand the population's access to healthcare. Strengthening the SUS and the Health Economic and Industrial Complex means making more medicines, vaccines and services available to Brazilians," said Marco Krieger, vice president of Production and Innovation in Health at Fiocruz.

In addition to being a beneficial partnership for users of the Unified Health System (SUS), this is an action that meets the National Strategy for the Development of the Health Industrial-Economic Complex, established by Decree No. 11.715, of 9/26/2023. The decree aims to expand domestic production of priority items for the SUS and reduce Brazil's dependence on imports of medicines, supplies and other items.

Approved in Brazil, Xeljanz® has been incorporated into the SUS and has a mechanism that acts inside cells, inhibiting Janus kinase (JAK), an important protein in the inflammatory processes characteristic of some immune-mediated diseases. The product also inaugurated a class of medicines for rheumatoid arthritis, becoming the first oral, non-biological, target-specific treatment for the disease, of the DMARD (disease-modifying drugs) type.

"More than 12,000 patients have already benefited from Xeljanz in Brazil's public health network. Now, through this partnership, we have strengthened our commitment to ensure that this innovation reaches even more people and thus transforms their lives," comments the president of Pfizer Brazil, Marta Díez. "This partnership also reinforces our commitment to strengthening Brazil's Health Economic-Industrial Complex," adds Marta.

The technology transfer of tofacitinib citrate from Pfizer to Farmanguinhos/Fiocruz will take place in stages. A registration for the clone of the drug molecule to be manufactured, for example, has already been submitted to the Brazilian Health Regulatory Agency (Anvisa). When approved, it will be possible for the Institute to start supplying the generic to the SUS, according to demand from the Ministry of Health (MS).

"One of the projects carried out at Farmanguinhos is focused on high value-added medicines. In other words, those of difficult access for the Brazilian population due to their high cost. With this partnership, we will be able to produce this medicine in our country, facilitating the treatment of patients suffering from such severe diseases," said the Institute's director, Jorge Mendonça.

Rheumatoid arthritis

According to the Brazilian Ministry of Health's 2021 Clinical Protocol and Therapeutic Guidelines (PCDT) for Rheumatoid Arthritis, the disease is more common in women aged between 30 and 50, with a peak incidence in the fifth decade of life. A family history increases the risk of developing the disease by three to five times. Symptoms include joint pain and swelling and, if left untreated, significant and irreversible joint damage can occur.