Brazil to expand local production of biologic drugs with 14 new products

With the help and co-ordination of the Ministry of Health (MoH), 27 public and private laboratories in Brazil have engaged in partnerships for the domestic manufacturing of 14 biological drugs. The announcement was made on 18 June in Brasilia by Minister of Health Alexander Padilha during a meeting of the Executive Group of the healthcare industry (GECIS), according to Investimentos e Noticias.

These partnerships have drawn from a new competitive model fostered by the government called Partnerships for Productive Development (PDP). Via the new partnerships, the government is aiming to increase the number of nationally produced biologic drugs to 25. According to the source, the products in question are high-technology drugs for the treatment of breast cancer, leukaemia, rheumatoid arthritis, diabetes, ophthalmology, and vaccines among others. Seventeen private laboratories are expected to transfer technology to eight public laboratories, with the agreements for each drug often involving two or more public and private partners. With these new agreements on biological drugs, the number of PDPs in the country rises to 90, involving the technology transfer of 77 products overall.

In terms of treatments, the PDPs are aimed at reducing the risk of the government experiencing shortages if an international manufacturer decides to stop production of a drug it exports to Brazil, as in the case of pediatric leukaemia drug L-asparaginases (Elspar; Lundbeck, Denmark) earlier this year. This drug will now be produced locally through a partnership between state laboratory Fiocruz and private laboratories NT Pharma and United Biotec. Domestically produced L-asparaginase is expected to be on the national market by 2015, and the government is expected to spend an average of BRL18 million (USD8 million) to purchase the drug per year. Furthermore, the recently announced PDPs will also entail the manufacturing of some of the most expensive biological drugs, including rheumatoid arthritis drug adalimumab and breast cancer drug trastuzumab.

Outlook and implications

With this move the government is expected to foster competition in the sector of biosimilars as domestic and international public and private partners are expected to compete for the same position in the market, enhancing the production of biosimilars and biotechnology drugs domestically. Furthermore, these partnerships, and specifically those with international manufacturers, are strategic from the government's perspective as it will speed up the creation of technology-transfer agreements in the country, which usually take up to five years to be established, in order to achieve 100% domestic production in the medium-to-long term.

Aside from enhancing a competitive production environment, the PDPs are expected to benefit the Brazilian healthcare sector and specifically the public sector, as well as patients, who will be able to take advantage of a variety of new treatment options. With 14 new biologic drugs expected to be created via the PDPs, the number of biologics available in the country will increase to 25.

In terms of the implications on budget, the Brazilian government is expected to achieve consistent savings through domestic production of biological drugs, as the products that will be manufactured via PDPs currently represent an expenditure of BRL1.8 billion per year in Ministerial Public tendering (source: Investimentos e Noticias). Furthermore, the national production of drugs is expected to generate revenues of BRL225 million per year (source: Investimentos e Noticias). The PDPs represent a positive opportunity for international manufactures involved in the agreements as they will enhance opportunities to expand their business in one of the fastest growing pharmaceutical and biologic markets of Latin America.