FDA Approves Ogivri, Mylan’s Biosimilar Version of Herceptin

Today, the FDA announced that it has approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar to Genentech and Roche’s Herceptin (trastuzumab).  Ogivri is indicated for adjuvant treatment of breast cancer and treatment of metastatic breast cancer or stomach cancer in patients whose tumors overexpress the HER2 gene.  Ogivri is the first biosimilar version of trastuzumab to receive FDA approval, and the first biosimilar approved in the U.S. for the treatment of stomach cancer.  Ogivri is the second biosimilar approved in the U.S. for the treatment of cancer, after Mvasi, Amgen and Allergan’s biosimilar version of Avastin (bevacizumab), which was approved in September.

As we previously reported, Ogivri was jointly developed by Mylan and Biocon.  In August, the two companies requested withdrawal and re-submission of their applications for marketing authorization for Ogivri in the European Union in view of a re-inspection of the Biocon manufacturing plant.  Shortly thereafter, FDA notified Mylan that it would extend the target action date for Ogivri from early September to December 3, 2017.  Several weeks ago, Mylan and Biocon resubmitted their Marketing Authorization Application for Ogivri to the European Medicines Agency.

Mylan previously announced that it had entered a license agreement with Genentech and Roche to commercialize Ogivri in the United States and elsewhere.