Biosimilars in Brazil: developments in 2015 and business perspectives




Brazil is looking into foreign technology to foster innovation in the country’s industrial health complex. Biological plants are being built and partnerships with multinationals have been established with the goal to in license technology, manufacture and supply the population with biosimilars made in Brazil. This article brings up-to-date information on the biosimilar market in the country, with information on the public-private partnerships and regulatory approvals. With two biosimilars approved in 2015 and the ongoing development regarding the local pharmaceutical companies, there is a good window of opportunity to create new businesses in the soon to be 4th pharmaceutical spender in the world.


Schmidt, M.I., Duncan, B.B., Azevedo e Silva, G., Menezes, A.M., Monteiro, C.A., Barreto, S.M., Chor, D. and Menezes, P.R. (2011) Chronic non-communicable diseases in Brazil: burden and current challenges. The Lancet 377(9781):1949–1961.

Interfarma. (2015) Comparações Internacionais no Coméricio de Produtos Farmacêuticos e Balança Comercial Brasileira de Medicamentos. Interfarma report, May,, accessed 1 October 2015.

Adriano Massuda. (2015) Seminário Valor Econômico: Indústria Farmacêutica Brasileira_Uma agenda para Inovação. Presentation, August,, accessed 1 October 2015.

Ministério da Saúde (2014) Portaria 2531 de 12 de Novembro, accessed on 4.10.2015.

Ministério da Saúde (2014) Portaria 2888 de 30 de Dezembro de 2014, accessed on 25.10.2015

Rocha, M.M. (2013) Drug Registration in Brazil: Challenge or Opportunity. Regulatory Focus, accessed on 2.11.2015.

Sheftelevich, Y. and Tripathi, S.C. (2010) Opportunities and Challenges in Latin America. Genetic Engineering and Biotechnology News, June 15, 30 (12),, accessed on 2.11.2015.

Castanheira L. G.; Barbano D. B.; Rech N. (2011) Current development in regulation of similar biotherapeutic products in Brazil, Biologicals, 39(5): 308-311, doi: 10.1016/j.biologicals.2011.06.021.

Business Wire (2015) February 24,, accessed on 2/10/2015

Dinwoodie N (2011) Biobetters and the Future Biologics Market BioPharm International 24 (11), accessed on 25.10.2015.

Plano Brasil Maior,, accessed on 29.10.2015.

Valor Econômico Especial Desafios da Saúde (2013), June 26,, accessed on 02.11.2015.

Dalgaard, K. Evers, M. and Silva, J.S. (2013), Biosimilars Seven Years : Where are we and what’s next, McKinsey & Company, February.

Biotechnology Institute,, accessed on 15.10.2015.

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