Categories: Approval

Biocon, Mylan’s Biosimilar Trastuzumab gets ANVISA’s approval

Mumbai, Janaury 04, 2018: Biotechnology mAJOR, Biocon and Mylan have received approval for Biosimilar Trastuzumab from ANVISA, the Brazilian regulatory agency, through their partner 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 overexpressing 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.

United News of India

The Pharma Times News Bureau

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