BRA. Brazil approves its first trastuzumab biosimilar
4 enero 2018

The first biosimilar version of Roche’s Herceptin (trastuzumab) has been approved in Brazil by the National Sanitary Vigilance Agency (ANVISA), the country’s medicines regulatory body. The new product, co-developed by Biocon (India) and Mylan (Netherlands), was approved by ANVISA through leading Brazilian pharmaceutical company Libbs Farmaceutica.

Libbs will commercialize the product in Brazil under the brand name Zedora, providing affordable access to advanced biologics therapy for patients in the South American nation. Trastuzumab, which has been included on the WHO list of essential medicines, is indicated for the treatment of breast cancer and advanced gastric cancer.

ANVISA’s approval is significant, as it constitutes a definitive step for the entry of the biosimilar version of trastuzumab into the country. Libbs’ chief executive, Alcebíades de Mendonça Athayde Júnior, stated that Zedora “can help expand cancer-patient access to more affordable treatment and contribute to significant savings to Brazil’s healthcare system. Zedora will strengthen our current product portfolio as a new generation targeted therapy that can benefit cancer patients immensely.” Brazil is one of the top three emerging global markets for trastuzumab. The Brazilian pharmaceutical market is expected to reach US$30 billion in 2021, a 15% from 2016 levels. Breast cancer is a leading cause of death in women in Brazil, being the second-most common type of cancer that affects Brazilian women.

Local production on the horizon

For the time being, the trastuzumab will be manufactured by Biocon and supplied to Libbs for commercialization in Brazil. However, in time, Biocon and Mylan intend to transfer the technology to Libbs and the public partner Butantan through a productive development partnership (PDP). The Brazilian laboratory has already built the biotechnological facility to produce Zedora for the local market.

Global ascendance

The Biocon – Mylan partnership had recently reached another key achievement when the US’s Food and Drug Administration approved their biosimilar trastuzumab. The drug, which has already approved in other countries such as India, is currently under review by regulatory authorities in Australia, Canada and Europe, among other markets.

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