(RTTNews) - Pharmaceutical company Mylan N.V. (MYL) and India-based Biocon Ltd. announced Monday the U.S. launch of Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab). The product is co-developed by Mylan and Biocon.
Ogivri was the first biosimilar trastuzumab approved by the U.S. Food and Drug Administration (FDA) and unanimously recommended by the FDA Oncologic Drugs Advisory Committee (ODAC). Ogivri is available in a 420mg multi-dose vial and a 150mg single-dose vial in order to provide patient dosing and treatment flexibility.
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).
Two supplemental Biologics License Applications were recently approved by the FDA, expanding the manufacturing capability for Ogivri, as well as Mylan and Biocon's first U.S. biosimilar, Fulphila, a biosimilar to Neulasta.
Mylan and Biocon Biologics have sufficient manufacturing capacity to fulfill demand in the U.S. and global markets for both products.
FDA approval of Ogivri was based on robust data demonstrating that Ogivri is highly similar to Herceptin and no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency
Long-term results of the landmark HERITAGE study including overall survival data at 36 months were presented at this year's American Society of Clinical Oncology (ASCO) Annual Meeting.
Ogivri is the second biosimilar to be offered by Mylan through the Mylan-Biocon Biologics partnership in the U.S. and the second FDA-approved biosimilar through this collaboration to support cancer patients. Mylan and Biocon launched the world's first biosimilar trastuzumab in India in 2014.