Samsung Bioepis has received Brazilian Ministry of Health approval for Brenzys, an Enbrel biosimilar product. In Brazil, 90%+ of autoimmune disease treatments (e.g. Enbrel, Humira & Remicade) are available via the nation’s productive development partnership (PDP) program—where a global biopharma sponsor, a Brazilian biopharma company and a national Brazilian research institute enter into a three-party partnership. The global company shall transfer the production technology to the local Brazilian company (Bionovis) and research center (Bio-Manguinhos).
The Brazilian PDP Programs
The Brazilian Productive Development Partnership program combines a global biopharmaceutical company, a Brazilian pharmaceutical company, and a national research institute that enter into a three-party relationship. Through the partnership, the global biopharmaceutical venture offers the product (in this case, Brenzys) while transferring its production technology to both Bionovis and Bio-Manguinhos for 10 years, reports the Korea Biomedical Review.
Brazilian Growth Rate
Brazil is experiencing rapid biopharmaceutical product growth with more than 9.5% over the past five years. The market size is expected to hit $29.7 billion by 2021.
Bio-Manguinhos, a national research institute, has a strategic role for the Ministry of Health in Brazil. It is one of the largest public producers of vaccines in Latin America, which reaches health centers through the National Immunization Program. Its products protect against yellow fever, polio, meningitis A and C, measles, mumps and rubella (MMR), rotavirus, Hemophilus influenza type b (Hib)-bacteria that can cause different diseases, meningitis and one of the most serious, and against pneumococcus bacteria, preventing bacteria meningitis, pneumonia and otitis media.
Bio-Manguinhos is the most prominent institution of Health Science & Technology in Latin America. Bio-Manguinhos is one of Fiocruz’s 16 technical-scientific units. In 2014, it accounted for 58.82% of the vaccines produced in Brazil and used by PNI when delivering 103,636,623 doses of vaccines. 9,590,777 vials of biopharmaceuticals and 5,839,396 diagnostic reagents were delivered. Since 2001, with the pre-qualification of the yellow fever vaccine by the World Health Organization (WHO), it operates in the international public market through its surplus production for SUS and has supplied the vaccine to 74 countries. As a result of its portfolio of projects and technological development, the Institute’s portfolio consists of: 10 vaccines, four biopharmaceuticals and 11 diagnostic reagents.
Bio-Manguinhos is an institution in constant growth and transformation. In recent years, this movement has intensified. The unit has been expanding its infrastructure and will operate a new plant in the Santa Cruz Industrial District of Rio de Janeiro: the Health Biotechnology Industrial Complex (CIBS). In order to expand the supply of vaccines and biopharmaceuticals to public health programs, the campus It will house the New Final Processing Center (NCPFI), as well as areas dedicated to quality assurance and control. The venture will increase the possibilities for partnerships for technological development and Brazil’s competitiveness in the biotechnology sector. In addition, in line with Fiocruz’s policy of deconcentrating technological development and national expansion, a new campus is being set up in Ceará, located at the Industrial Technological Health Center (PTIS) in the municipality of Eusébio. Bio will deploy a new facility on site, being the Institute’s first industrial plant outside the state of Rio. The area will be dedicated to plant-based technologies.