Biocon and Mylan’s proposed trastuzumab has received approval from Brazilian regulatory agency ANVISA, through their partner Libbs Farmaceutica (Libbs). The approved product is co-developed by Biocon and Mylan.

Biocon in a regulatory filing stated that, this is the first biosimilar trastuzumab to be approved in Brazil. It further stated that, currently biosimilar trastuzumab will be manufactured by it and supplied to Libbs for commercialization in Brazil.

Furthermore, Arun Chandavarkar, Biocon CEO and Joint Managing Director stated, “Cancer patients in India and some emerging markets have benefited with our trastuzumab and the approval in Brazil will enable affordable access to this critical biologic therapy for treatment of HER-2 positive breast and gastric cancer in the country.”

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