A biosimilar of cancer drug Herceptin (trastuzumab) has been launched in the US by Mylan and Biocon.
Ogivri (trastuzumab-dkst) was the first biosimilar trastuzumab approved by the US FDA and unanimously recommended by the FDA Oncologic Drugs Advisory Committee (ODAC).
It 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).
Trastuzumab and biosimilar trastuzumab products contain a Boxed Warning for cardiomyopathy, infusion reactions, pulmonary toxicity and embryo-foetal toxicity.
Approval 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.
Two supplemental Biologics License Applications were recently approved by the FDA, expanding the manufacturing capability for Ogivri.