Instituto Vital Brazil and PharmaPraxis, which is part of Brazilian drugmaker Axis Biotec, will be partners in a research project for the manufacture of adalimumab.

Adalimumab is a human-derived, genetically-engineered monoclonal antibody. The product acts to reduce excessive levels of human tumour necrosis factor (TNF) alpha, which plays an important role in abnormal inflammatory and immune responses.

It therefore acts as an anti-TNF therapy, which is approved by the EMA in the EU for the treatment of psoriasis, rheumatoid arthritis and Crohn’s disease.

Abbott Laboratories, which last year posted worldwide sales for Humira of US$6.5 billion, was apparently not involved in the deal to produce what appears to be a follow-on version of the monoclonal antibody in Brazil.

The news may come as a bit of a shock to Abbott, which only gained approval for Humira in the EU in September 2003 and in the US in February 2007, and was probably expecting a longer period of exclusivity before being challenged.

Editor’s comment
It should be noted, however, that follow-on biological products approved in Brazil may not have been authorized following as strict a regulatory process as is required for 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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