Brazil's Bionovis, Fiocruz, and Instituto Vital Brazil have entered into partnership with Germany's Merck Serono for the production of six biosimilar products for cancer and arthritis.
IHS Global Insight perspective | |
Significance | Brazilian firms Bionovis, Fiocruz, and Instituto Vital Brazil are partnering with Germany's Merck Serono for the production of six biosimilar products for cancer and arthritis: etanercept, rituximab, bevacizumab, cetuximab, infliximab, and trastuzumab. The technology-transfer agreement also involves the construction of a production plant in 2014. |
Implications | The technology-transfer agreement is expected to have a variety of positive results for the Brazilian biosimilars industry as it will expand the domestic sector with increased opportunities for public state laboratories and private national enterprises, as well as boosting technology innovation and knowledge in the field and further implementing the research and technology sector. |
Outlook | The agreement is expected to be a source of savings for the Ministry of Health as it will reduce costs of importing expensive biosimilar drugs through domestic production. If production is successful in the medium-to-long term, the pipeline of drugs is expected to be expanded. |
The Brazilian Ministry of Health (MoH) has announced that domestic pharmaceutical firms Bionovis, Fiocruz, and Instituto Vital Brazil have entered into partnership with Germany's Merck Serono for the production of six biosimilar cancer and arthritis products: etanercept, rituximab, bevacizumab, cetuximab, infliximab and trastuzumab, according to Parana online. Merck Serono has said that it will be working on transferring the technology for the production of the drugs during the next five years, starting in 2014. This is part of a wider government programme launched in June 2013 which involves 27 public and private laboratories engaging in partnerships for the domestic manufacture of 14 biological drugs as a result of a new competitive model fostered by the government called Partnerships for Productive Development (PDP; see Brazil: 25 June 2013: Brazil to expand local production of biologic drugs with 14 new products).
According to the source, the technology-transfer agreement, which also involves the construction of a production plant in 2014, will start with the training of Brazilian personnel. According to the source, as a result of the technology-transfer agreement, Merck agreed with the Brazilian government to sell the six drugs in question to the MoH at a 5% discounted rate, with the discount percentage increasing until the transfer is completed. The production of the six drugs in Brazil is expected in 2015.
Outlook and implications
The agreement is expected to have a variety of positive results for the Brazilian biosimilars industry as it would expand the national sector with increased opportunities for public state laboratories and private national enterprises, as well as boosting technology innovation and knowledge in the field, as well as further implementing the research and technology sector. Furthermore, the technology transfer should be a positive source of savings for the MoH, which will reduce costs of importing expensive biosimilar drugs through domestic production, starting with an initial pipeline of six essential biosimilars. If production is successful in the medium-to-long term, the pipeline of drugs available through the agreement is expected to increase.
With this move the government is expected to foster competition in the biosimilars sector as domestic and international public and private partners will vie for the same position in the market, enhancing the production of biosimilars and biotechnology drugs. Furthermore, these partnerships, and specifically those with international manufacturers, are strategic from the government's perspective as it will speed up the creation of future technology-transfer agreements, which usually take up to five years to be established, with the aim of achieving 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.