U.S. Biosimilar Launches: Mylan/Biocon’s Trastuzumab, Sandoz’s Pegfilgrastim

Yesterday, Mylan N.V. and Biocon Ltd. announced the U.S. launch of OGIVRI (trastuzumab-dkst), a biosimilar to HERCEPTIN (trastuzumab).  According to the press release, “OGIVRI™ is approved for all indications of HERCEPTIN® including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma),” and is available in both 420mg multi-use vials and in 150mg single-use vials.  OGIVRI is the second biosimilar launched in the U.S. from the Mylan-Biocon Biologics partnership, the first being FULPHILA (pegfilgrastim-jmdb).

OGIVRI marks the eleventh biosimilar to hit the U.S. market, and the second biosimilar launch in recent weeks.  As we previously reported, the FDA approved Sandoz’s biosimilar application for ZIEXTENZO (pegfilgrastim-bmez) in November.  Soon thereafter, Novartis launched ZIEXTENZO in the U.S.