Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

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
06 Dec 2017
Breast cancer;  Anticancer agents & Biologic therapy

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.

Last update: 06 Dec 2017

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings