PUCRS helps introduce biosimilars in Brazil
Photo: Jonathan Perez/Unsplash
The National Sanitary Surveillance Agency (Anvisa) has approved the production of the first biosimilar containing active ingredient trastuzumab in Brazil, to be commercialized by Libbs under the name Zedora. The product has been developed by Indian company Biocon, based on studies conducted by US company Mylan. Trastuzumab, which is indicated for breast cancer patients with HER2 protein overexpression (20% of the total), is less toxic and stimulates the reaction of the immune system. Additionally, it has shown to be effective in more critical cases (metastasis, that is, when the tumor spreads to other organs). Biosimilars, which are similar to reference medication and are used to fight oncological problems and disorders such as rheumatoid arthritis, are, on average, 30% cheaper than regular medication.
Zedora will be provided by the federal government through a partnership intended for the production of the drug, in which the technology will be transferred to the company and to Instituto Butantan, in the coming years.
Expanded access
Represented by School of Medicine professor Dr Marcio Debiasi, PUCRS has played an important role in the introduction of biosimilars in Brazil. Dr Debiasi took part int he study headed by Libbs at the Center for Clinical Research of São Lucas Hospital and was invited to begin the introduction of biosimilars in the country. Medical doctors representing each state in the country will inform their peers about the biological and molecular mechanisms of the drug.
Today, patients who need trastuzumab need to have a health plan (and a tumor larger than 2 cm), go to court or join a research protocol in order to get the medication. The federal government is accountable for around 60% of the purchase of medical drugs. These extremely costly drugs account for 43% of the Ministry of Health’s expenses on medication, but only 4% of the total number of drugs purchased. In Dr Debiasi’s view, now that the product is being produced locally, the plan is to make it more easily accessible.
Partnership with PUCRS
It might take some time until the Universal Health Care System (SUS) starts to offer trastuzumab. In the meantime, Debiasi is working on a research protocol with the company in order to bring short-term benefits to patients with HER2 overexpression. The study, which is being headed by PUCRS and being supported by researcher Dr Hope Rugo, from University of California San Francisco, is expected to target patients in hospitals of Brazil and all over Latin America.
