Biosimilar trastuzumab approved by Brazil's ANVISA

29 December 2017

The first biosimilar version of Roche’s (ROG: SIX) blockbuster Herceptin (trastuzumab) has been approved in Brazil by ANVISA, the country’s medicines regulatory agency. The originator drug brings in global sales of around $7 billion for Roche.

The biosimilar was co-developed by India’s Biocon (BSE: 532523) and Netherlands-incorporated Mylan (Nasdaq: MYL), and is partnered in this territory with Libbs Farmaceutica (Libbs), a leading Brazilian pharmaceutical company.

Co-developed by Biocon and Mylan, this is the first biosimilar trastuzumab to be approved in Brazil and is indicated for the treatment of over-expressing HER2-positive metastatic breast cancer, HER2-positive early stage breast cancer and HER2-positive advanced gastric cancer. Libbs will commercialize the product in Brazil under the brand name Zedora, which will provide affordable access to a cutting-edge biologics therapy for patients in Brazil, the companies stated.

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