Brazil’s medicines agency, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), announced on 27 April 2015 that it had approved its first follow-on biological medicine through ‘the development by comparability’.
The registration of the anti-inflammatory follow-on biological product Remsima (infliximab) produced by Celltrion was published in the country’s Official Gazette (Diário Oficial da União) on Monday 27 April 2015.
The comparability exercise was evaluated to demonstrate the similarity between Remsima and the comparator biological product, Remicade (infliximab). This was in accordance with the rules foreseen in RDC 55/2010, which establishes a specific pathway for follow-on biological products in Brazil.
The Brazilian regulations (Resolution no. 55/2010) are based on different regulations and guidelines from around the world, including the WHO’s Guidelines on Evaluation of Similar Biotherapeutic Products.They follow the same scientific principles as the WHO guidelines but contain some differences due to the specific needs of Brazil [1].
Remsima has been approved in Brazil for the treatment of ankylosing spondylitis, colitis and ulcerative rectocolitis, Crohn’s disease, psoriatic arthritis, psoriasis and rheumatoid arthritis.
Celltrion has already obtained approval for Remsima from over 50 countries worldwide, including most advanced regulatory agencies including Canada, Europe and Japan. The South Korean biotechnology company also filed a biosimilar application in the US for its infliximab biosimilar (CT-P13) back in August 2014, as the first monoclonal antibody to be filed in the US [2].
Editor’s comment
It should be noted that ‘follow-on biologicals’ approved in Brazil might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) 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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Prospects for producing follow-on biological products in Brazil
Brazilian guidelines for follow-on biological products
References
1. GaBI Online - Generics and Biosimilars Initiative. Brazilian guidelines for follow-on biological products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 4]. Available from: www.gabionline.net/Guidelines/Brazilian-guidelines-for-follow-on-biological-products
2. GaBI Online - Generics and Biosimilars Initiative. FDA receives application for monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 4]. Available from: www.gabionline.net/Biosimilars/News/FDA-receives-application-for-monoclonal-antibody-biosimilar
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