Farmanguinhos/Fiocruz, the Institute of Drug Technology in Brazil, has signed a technology transfer agreement with Pfizer Brazil for the manufacturing of tofacitinib citrate, a generic counterpart to Xeljanz.
The partnership, formalized on 20 December 2023 in Rio de Janeiro, aims to strengthen domestic drug production and improve public access to the treatment of immune-mediated inflammatory diseases, specifically those linked to imbalances in the immune system, such as rheumatoid arthritis.
According to Marco Krieger, Vice President of Production and Innovation in Health at Fiocruz, this agreement ‘is part of a structuring strategy by Fiocruz to continuously expand access to health care for the population. Strengthening the SUS (Sistema Único de Saúde) and the Health Economic and Industrial Complex means making more medicines, vaccines and services available to Brazilians’.
As well as being a beneficial partnership for (SUS) users, this action aligns with the National Strategy for the Development of the Health Industrial Economic Complex, established by Decree No. 11.715 of 26/9/2023. The decree aims to expand national production of priority items for the SUS and reduce Brazil's dependence on imports of medicines, supplies and other products.
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 involved in the inflammatory processes that are characteristic of certain immune-mediated diseases. The product has also pioneered a class of drugs for rheumatoid arthritis, marking the first non-biological, target-specific oral treatment for the disease within the DMARD type (disease-modifying drugs).
Marta Díez, President of Pfizer Brazil, emphasized the significance of the partnership, stating, ‘More than 12,000 patients already benefit from Xeljanz in Brazil's public health network. Now, through this partnership, we are strengthening our commitment to ensuring that this innovation reaches even more people, thus transforming their lives. Additionally, through this partnership with Fiocruz we are also reinforcing our commitment to strengthening Brazil's Health Economic-Industrial Complex’.
Farmanguinhos/Fiocruz will gradually transfer Pfizer's tofacitinib citrate technology. The registration for the molecule of the drug clone has already been submitted to ANVISA, the National Health Surveillance Agency. Upon approval, the Institute will be able to supply the generic drug to SUS, meeting the requirements of the Ministry of Health.
Farmanguinhos' Director, Jorge Mendonça, explained that one of their projects focuses on producing high value-added medicines, aiming to address the challenge of limited access for the Brazilian population due to high costs. Through this partnership, they seek to locally manufacture such medicines, thereby easing the treatment of patients with severe diseases.
In Brazil, by law, generic medicines must be 35% cheaper than the reference product, in practice, they are generally 60% cheaper. It is now possible to treat about 90% of the most common human diseases with generics. Among the 20 top prescribed drug products in Brazil, 15 have a generic drug alternative. A total of 76% of medicines dispensed in Brazil is generics. Generics have provided cumulative savings of more than BRL41 billion (US$21 billion) for the Brazilian population in the private market alone [1].
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. The Brazilian generics market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jan 30]. Available from: www.gabi-journal.net/news/the-brazilian-generics-market
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