Fresenius Kabi establishes partnership with Bio-Manguinhos/Fiocruz and Bionovis to provide access to adalimumab biosimilar in Brazil
This partnership will expand treatment options in the Brazilian Public Health System (SUS) for several autoimmune diseases
August 10, 2022
Fresenius Kabi, a healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition, announces a partnership with Fiocruz/Bio-Manguinhos and Bionovis for the production and supply of Fresenius Kabi’s adalimumab biosimilar, IDACIO®* in Brazil. The product is intended for the treatment of several autoimmune diseases in rheumatic, gastrointestinal and skin diseases, such as rheumatoid arthritis, Crohn's disease, and plaque psoriasis, among others.
IDACIO® (adalimumab) is Fresenius Kabi's first biosimilar to be approved and supplied in Brazil. This Productive Development Partnership (PDP) is expected to continue for the next ten years.
"We are enthusiastic about this partnership in Brazil, where we have built a solid history of success for more than 40 years. It is an important and promising milestone for our company and Brazil's patients, who will have access to a high-quality treatment through their public health system," said Hernâni Sério, General Manager of Fresenius Kabi Brazil.
The initiative will supply the Brazilian Ministry of Health and Brazil's public health system with Fresenius Kabi’s adalimumab biosimilar and facilitate more patient access to effective and more affordable treatment options for chronic and acute diseases in Brazil. IDACIO® (adalimumab), registered with the Brazilian Health Surveillance Agency (Anvisa) in August 2020, will be available for adult and pediatric indications. The drug will be made available free of charge to the population through the Brazilian Public Health System (SUS) by the second semester of 2022 onwards.
Fresenius Kabi will ensure full technology transfer to Bio-Manguinhos/Fiocruz and Bionovis, thus enabling the production and registration of the nationalized drug in Brazil.
* IDACIO® (adalimumab) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
About Fresenius Kabi
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. Fresenius Kabi’s product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the devices for administering these products. In the field of biosimilars, Fresenius Kabi focuses on autoimmune diseases and oncology. In 2019, the first biosimilar product by Fresenius Kabi was launched. Within transfusion medicine and cell therapies, Fresenius Kabi offers products for collection of blood components and extracorporeal therapies.
With its corporate mission of "caring for life", the company is committed to putting essential medicines and technologies in the hands of people who help patients and finding the best answers to the challenges they face.
Fresenius Kabi employs more than 41,000 people worldwide. In 2021, the company reported sales of more than €7.1 billion. Fresenius Kabi AG is a wholly owned subsidiary of the Fresenius SE & Co. KGaA healthcare group.
For further information, visit the company's website on https://www.fresenius-kabi.com/br.
As part of the Brazilian Ministry of Health, for 46 years the Institute of Technology on Immunobiologicals of the Oswaldo Cruz Foundation (Bio-Manguinhos/Fiocruz) has expanded access to health care for the population through the research, development and supply of products that prevent, diagnose and treat diseases. To establish itself as the largest public laboratory in Latin America, Bio-Manguinhos wrote parts of the History of Public Health in Brazil. It has played a decisive role in the eradication of poliomyelitis in the country and in the Americas; was instrumental in the control of measles and yellow fever, becoming one of the main producers of this vaccine in the world, having already exported to more than 70 countries.
Partnerships with public and private institutions through technology transfer agreements, Partnerships for Productive Development (PDPs) and autochthonous development projects contribute to the expansion of its portfolio, which has more than 40 products among vaccines, in vitro diagnostics (IVDs) and biopharmaceuticals. Each year, millions of units are provided to the Brazilian Ministry of Health programs.
Find out more online at https://www.bio.fiocruz.br/index.php/en-us/bio-eng
About the Oswaldo Cruz Foundation (Fiocruz)
The Oswaldo Cruz Foundation (Fiocruz) was founded by Dr. Oswaldo Cruz, a noted physician and epidemiologist and is considered one of the world's main public health research institutions. Fiocruz is a scientific research foundation focussed on biological sciences, located in Rio de Janeiro, Brazil and part of the Brazilian government's Ministry of Health. It has one of Brazil’s largest public laboratories for vaccine production - the Institute of Technology on Immunobiologicals (Bio-Manguinhos). Bio-Manguinhos is the world’s largest manufacturer of the yellow fever vaccine, and the only Latin American laboratory certified by the World Health Organization (WHO) for this purpose.
Learn more at https://portal.fiocruz.br/en.
Bionovis is a Brazilian biopharmaceutical company whose objective is to promote research, development, production and commercialization of highly complex biologics in Brazil.
For this purpose the company completed the construction of the first stage of its industrial unit in the city of Valinhos, state of São Paulo, where more than R$ 600 million has been invested in manufacturing infrastructure so far, in addition to bringing in highly qualified human resources and acquiring technology to the country.
This investment will allow the integral and sustainable production of several biosimilar biological medicines and innovative biopharmaceuticals for the treatment of various pathologies, including autoimmune and oncological diseases.
Learn more at www.bionovis.com.br