Bionovis defines factory and has vouched for biological

The Bionovis, national superfarmacêutica designed to produce and develop biological medicines and biosimilars, announces today in Brasilia, during meeting of the Executive Group of the Health Industrial complex (Gecis), Ministry of health, which will build its first plant in Rio de Janeiro. Three States were in the running to receive investment-in addition to Rio, São Paulo and Santa Catarina.
The plans of the new company, founded last year, are investing about r $ 500 million, which includes the construction of the unit and the development of medicines. The Bionovis, whose shareholders Drugmakers Aché, EMS, Chemical and Union Hypermarcas-each with 25%-has the federal Government as an important ally.
The federal Government will be the main buyer of drugs produced by superlaboratório and see in this initiative a chance to reduce the deficit of the trade balance of the billionaire health, that in 2012 has reached about $ 11 billion. Of this total, $ 6,114 billion corresponded to the purchase of medicines and ready $ 2.612 billion active principles. The country also imports diagnostic equipment.
Two other national companies-the Orygen, joint venture between Biolab, Cristália and Eurofarma-and Libbs, which acts independently, are also directly involved in the project to nationalize the production of medicines for complex treatments, such as cancer and rheumatoid arthritis.
The national agency of sanitary surveillance (Anvisa) will give the go ahead for the achievement of clinical studies of Biosimilar medicines already in development in the country. The Agency details today on the regulation for the development of these products, which includes the route of comparability-that allows the registration of the medicinal product with the product that is on the market-and individual route, which proposes the procedure of evaluation of clinical studies as a new product.
Anvisa has already approved the manufacture of Etarnecepte, which deals with rheumatoid arthritis, in development by Bionovis, in partnership with public laboratories. Libbs also should receive today the Agency's approval to carry out clinical trials of rituximab.
To Reginaldo Arcuri, President of Farma Brazil, representing the national capital pharmaceutical laboratories, the Government's decision to support the biological development in the country is the effective and concrete first step to consolidate the national pharmaceutical industry. Anvisa's measures, he said, are considered the pioneers in establishing the two routes.
The Ministry of health has signed 64 PDPs (Productive development product), involving 15 national laboratories and about 40 private pharmaceutical. These partnerships are for technology transfer for the production of medicines to public laboratories. The Government should announce today 10 new PDPs for biological medicinal products, which will include medicines for cancer and chronic inflammatory diseases, involving the superlaboratórios.
PDPs stimulate the nationalization of important medicines. In recent years, the importation of drugs has surpassed that of active ingredients, particularly on account of the high costs of the products to complex treatments. The federal government accounts for about 60% of organic purchases in the country. Although the biological equivalerem about 5% of the medicines purchased by the Ministry of health, they represent 43% of spending. With the national, the Ministry plans to Biosimilars save r $ 4 billion on purchases for the unified Health System (SUS).