FDA Approves Ogivri as a Biosimilar to Herceptin

First biosimilar approved in the US for the treatment of patients with breast and gastric cancer whose tumours overexpress the HER2 gene

On 1 December 2017, the US Food and Drug Administration (FDA) approved Ogivri ( trastuzumab-dkst, Mylan) as a biosimilar to Herceptin (trastuzumab, Genentech, Inc.) for the treatment of patients with HER2-overexpressing breast or metastatic gastric or gastro-oesophageal junction adenocarcinoma.

The drug is the first biosimilar approved in the US for the treatment of breast cancer or gastric cancer and the second FDA-approved biosimilar for the treatment of cancer.

Healthcare professionals should review the prescribing information in the labelling for detailed information about the approved uses here.

Approval was based on comparisons of extensive structural and functional product characterisation, animal data, human pharmacokinetic and pharmacodynamic data, and clinical studies including clinical immunogenicity between Ogivri and US-licensed Herceptin. These data demonstrate that Ogivri is highly similar to US-licensed Herceptin and that there are no clinically meaningful differences between the products.

Ogivri has been approved as a biosimilar, not as an interchangeable product.

Common expected side effects of Ogivri for the treatment of HER2-positive breast cancer include headache, diarrhoea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash.

Common expected side effects of Ogivri for the treatment of HER2-positive metastatic gastric or gastro-oesophageal junction adenocarcinoma include neutropenia, diarrhoea, fatigue, anaemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.

Serious expected side effects of Ogivri include worsening of chemotherapy-induced neutropenia.

Like Herceptin, the labelling for Ogivri contains a Boxed Warning to alert healthcare professionals and patients about increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-foetal toxicity.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.