On December 29, Mylan and Biocon announced that their trastuzumab biosimilar, Zedora, was approved by Brazil’s National Sanitary Surveillance Agency. Zedora, a biosimilar of Genentech and Roche’s Herceptin, is indicated for the treatment of overexpressing HER2-positive metastatic breast cancer, HER2-positive early stage breast cancer, and HER2-positive advanced gastric cancer. Zedora is the first trastuzumab biosimilar approved in Brazil and will be commercialized by Mylan and Biocon’s Brazilian partner, Libbs Farmeceutica.
As we previously reported, Mylan and Biocon gained FDA approval of the same drug, marketed as Ogivri (trastuzumab-dkst) in the US. The partnership’s trastuzumab biosimilar is also currently under review by regulatory authorities in Europe, Australia, Canada, and several other markets.