Biocon announced yesterday that it has received marketing authorization approval from the European Commission for Semglee™ (insulin glargine). The decision came after receiving a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. According to the press release, this is the first…
Clover Biopharmaceuticals, a clinical-stage biotech company based in Chengdu, China, and General Electric announced last week that Clover had selected General Electric’s FlexFactory biomanufacturing platform for Clover’s new manufacturing facility, to be located in the Changxing Economic and Technological Development Zone. The facility, which is scheduled to open in the second half of 2018, will feature…
Last week, Sandoz announced a new collaboration with Asian biopharmaceutical company Biocon to “to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide. Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of…
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…