ANVISA has authorized the company to manufacture biotechnology drugs at its industrial complex located in Itapira City (São Paulo).

‘This is the first national plant with a certificate of good manufacturing practices (GMP) issued by ANVISA for the manufacturing of active pharmaceutical ingredients obtained through biotechnology’, according to Dr Ogari Pacheco, President and Co-founder of Cristália.

Cristália will manufacture the active pharmaceutical ingredients trastuzumab, etanercept and somatropin for drugs used in cancer, rheumatoid arthritis, psoriasis and hormone human growth treatments.

The drugs have been developed in collaboration with the Korean laboratory Alteogen and are expected to generate a turnover of BRL 300–400 million per year. Cristália started manufacturing of the active ingredients by end of March 2014, which will be used in clinical trials that are to be completed in 2.5 years. Data from these pivotal trials are expected to support applications for approval with ANVISA.

Editor’s comment
It should be noted that ‘follow-on biological 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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