Libbs, a national pharmaceutical industry, will inaugurate in the second half this year the first plant of biological medicines in Brazil, to produce monoclonal antibodies on an industrial scale.
The plant, which is practically ready, was built in record time. Every phase required by a project of such magnitude, of highly complexity, was fulfilled in a challenging deadline for the team, that is, 18 months. Last February, the cell bank of the drug rituximab arrived in Brazil. In March, the first pilot batch was started to test the production process.
According to the director of unit B2B at Libbs, Marco Dacal, there are five productive development partnerships signed with the Government for the production of five drugs in the company plant. These are four monoclonal antibodies and one fusion protein. Individually: rituximab, bevacizumab, trastuzumab, adalimumab – monoclonal antibodies- and etanercept – the fusion protein.
In addition to these drugs, last March 9th, Libbs signed a letter of support that includes it in a project run by the Utrecht University, in the Netherlands. The project aims at the development of biosimilar palivizumab, a monoclonal antibody that prevents infection by respiratory syncytial virus in premature babies.
The project will be coordinated by the Utrecht University (The Netherlands), with support from the World Health Organization (WHO) and developed by mAbxience, the Chemo group, by Libbs, Medigen, Taiwan pharmaceutical industry and by Spimaco, Saudi Arabia pharmaceutical industry.
“The main objective of this project is to develop, test and approve the palivizumab to be marketed in all countries at an affordable price, since this medicine can save many lives; however, its cost is very high, not allowing wide access for all babies who need this medicine”, explains Dacal.
The director of Institutional Relations at Libbs, Márcia Martini Bueno, explains that rituximab will be the first biological medicine to be launched by Libbs in Brazil. “The product has undergone the first clinical study of a biosimilar monoclonal antibody, led by a Brazilian pharmaceutical company. This is a globally conducted study, just like the other ones. We intend to apply for registration with the National Health Surveillance Agency (Anvisa) in the first half of 2017”, says Márcia.
Monoclonal antibodies are considered second generation biological medicines. In addition to the complex production process, these therapies are considered the most modern in the treatment of cancer and autoimmune diseases. However, worldwide, these products represent a high cost for treatment. “In this sense, Libbs decided to invest in these products, as believes that the access of patients to their respective treatment will be expanded, reducing the dependence of Brazil regarding import of high-cost drugs and, eventually, supporting the national scientific development”, concludes Dacal.