China only approved its first biosimilar drug in 2019, but the market is already looking too crowded for one Big Pharma company. Pfizer has halted its biosimilar programs in China and is selling a biologics facility there to Chinese CDMO giant WuXi Biologics, the company said in a statement Wednesday. The “difficult decision” came after a… Read More »
FDA Approves Ziextenzo (pegfilgrastim-bmez), a Biosimilar to Neulasta Print this page Holzkirchen, Nov. 5, 2019 – Sandoz, a Novartis division and a global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar Ziextenzo (pegfilgrastim-bmez). Sandoz biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo® (pegfilgrastim) since… Read More »
FDA Approves Kanjinti (trastuzumab-anns), a Biosimilar to Herceptin Print this page THOUSAND OAKS, Calif., June 13, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Kanjinti (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab): for the treatment of HER2-overexpressing adjuvant… Read More »
Print this page INCHEON, KOREA – January 21, 2019 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Ontruzant (trastuzumab-dttb), a biosimilar referencing Herceptin®i (trastuzumab), across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma… Read More »