The deal between Merck Serono and the Brazilian firms was arranged by the Ministry of Health as part of its Productive Partnerships for Development [Parcerias para o Desenvolvimento Produtivo (PDP)] initiative, through which the ministry is encouraging domestic production of biologicals.

The products, which will be manufactured by Bionovis and public institutes Fiocruz and IVB, include bevacizumab, cetuximab, etanercept, infliximab, rituximab and trastuzumab. The agreement with Merck Serono will ensure transfer of the technology for production of the drugs during the next five years, starting in 2014. The deal also involves the construction of a new production plant to produce the six drugs in 2014.

Currently, biologicals consume 43% of the resources of the Brazilian Ministry of Health, costing about US$4 billion per year, despite representing only 5% of the drugs purchased. Shifting to domestic production is expected to generate US$225 million in savings per year.

In June 2013, the Ministry of Health announced 27 new partnerships between public and private laboratories resulting in domestic production of 14 biologicals. With this latest deal the number of biologicals manufactured locally will increase to 25.

Editor’s comment
It should be noted that ‘similar biotherapeutic products’ approved in Brazil might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. EMA regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

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