Brazil spends BRL$491 billion (US$220 billion) on health care. This includes BRL$49.6 billion (US$21.6 billion) for pharmaceutical drugs and BRL$5.35 billion (US$2.4 billion) for biologicals. Despite rising costs, Brazil’s Minister of Health, Alexandre Padilha, has stated that ‘Brazil firmly believes in universal access and supports all initiatives that promote universal healthcare’.

Growing demand for expensive biologicals is putting a strain on Brazil’s National Public Healthcare System SUS (Sistema Único de Saúde). Brazil is therefore assessing multi-faceted programmes and partnerships that facilitate the introduction of follow-on biological products.

The Brazilian Government is actively encouraging local production of follow-on biological products via its Productive Development Partnership (PDP) initiative. The Ministry of Health coordinated PDP initiative hopes to generate US$225 million in savings per year by stimulating innovation, technology transfer and development of Brazilian-based companies [2].

In June 2013, the Ministry of Health announced 27 new partnerships between public and private laboratories resulting in domestic production of 14 biologicals. On 7 November 2013, a partnership between Brazil’s Bionovis, Fiocruz and Instituto Vital Brazil with Germany’s Merck Serono for the production of six follow-on biological products for cancer and arthritis was announced by the Brazilian Ministry of Health (Ministério da Saúde). To date, such arrangements should allow 25 biologicals to be manufactured locally [3].

Biosimilar development is a high-risk activity demanding significant resources with costs of around US$75–250 million compared to the cost of developing a small molecule generic (US$1–3.5 million). On top of this is the cost of building a biologicals manufacturing facility, which is expected to be in the range of up to US$400 million. Therefore, using Contract Development and Manufacturing Organizations (CDMOs) specialized in the manufacturing of complex biologicals could be one option Brazil investigates in order to produce domestic follow-on biological products.

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 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.

Related articles
Brazil speeds up approval process for generics and biologicals

Brazil’s ANVISA approves Cristália for production of ‘follow-on biological products’

References
1.   Lezzi. Contract Development and Manufacturing Organizations (CDMO): are they needed in Brazil. BMC Proceedings. 2014:8(Suppl 4):O3.
2.   GaBI Online - Generics and Biosimilars Initiative. The Brazilian generics market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Reports/The-Brazilian-generics-market 
3.   GaBI Online - Generics and Biosimilars Initiative. Merck Serono to transfer technology for six similar biotherapeutic products to Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Biosimilars/News/Merck-Serono-to-transfer-technology-for-six-similar-biotherapeutic-products-to-Brazil

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2015 Pro Pharma Communications International. All Rights Reserved.