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Company: Fleming Europe [Slovakia] 

Dates: November 18th and 19th, 2015
Location: Sao Paulo, Brazil

Venue: Tivoli Sao Paulo – Mofarrej

# of Booths: 2
# of Interpreters: 4

Event Summary

Recent improvements in local regulation, added to the high expertise and development of biosimilars in the region are encouraging

multinational pharmaceutical companies to enter this emerging market. Global pharmaceutical companies are partnering with local businesses to penetrate the market, with the idea of producing and  ommercialising locally and internationally. The first biosimilar to enter the region was insulin, followed by interferon and more recently monoclonal antibodies (mAbs). The last ones are still in an early stage and need further development. MAbs represent an opportunity for areas such as oncology, allergology and rheumatoid arthritis, and will probably widen the biosimilars market, but currently are far more expensive than other biologics.

The Brazilian healthcare system provides universal access to health to the population, and since 2012 has been discussing with some companies for the nationalization of some biologic drugs, through the productive development partnership policy (PDPs) and the support from BNDES. Choosing biosimilars over innovators would reduce healthcare spending by offering lower-cost alternatives to high-priced biologics.

The Biosimilars market is expected to boom in the next two years partly because of the patent expiration for most of the blockbuster biologics.

In the past some biosimilars got approval under a more lax regulation, but a more exhaustive one will be required in the future, ensuring higher quality and control. Establishing a rigorous regulation will stimulate market growth, which is expected to grow through Latin America at a significant rate in the next few years.

The challenge ahead is to offer similar safety and effectiveness as the innovators, while complying with global quality standards and at the same time maintaining lower prices.

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